REQUEST FOR FDA 510K PROPOSAL

1. MANUFACTURER INFORMATION
Legal Manufacturer / OEM / OBL Name*
Street*
City /Pincode*
Country*
Website Address
2. ADMINISTRATIVE INFORMATION
Role of the 510k applicant	Select Design, manufacture and distribute the medical device Design, Develop and distribute but, but manufacture from a different facility
Status of GMP	Select 21 CFR 820 Implementation is in progress 21 CFR 820 Implemented 21 CFR 820 & ISO 13485/MDSAP Implemented 21 CFR 820 and IEC/ISO 62304 Implemented Not aware about 21 CFR 820 21 CFR 820 Not Implemented
3. MEDICAL DEVICE DESCRIPTION
Name of the Medical Device*
FDA Product Code(s)*
FDA Regulation Number(s)
Predicative Device 510k Number(s)*
Device class*	Select Class I Class II Class III
Intended use of the device
Brand Name / Trade Name
Number of Models*	Select ONE TWO 1-5 1-10 1-20 1-40 1-100 1-1000
Difference between the Models	Select Design difference Measurement/size difference Color difference Raw Material / Construction material difference Difference in software Software version difference Intended use
Device Body Contact*	Select Not Applicable Software as a Medical Device External Body Contact Non Body Contact Less than 1 minute Less than 2 minutes Less than 5 minutes Less than 60 minutes Less than 30 days More than 30 days
Device Invasive action by	Select Not Applicable With the help of surgical procedure Body orifice Totally introduced into the body through surgical procedure Partially introduced into the body through surgical procedure
Type of Medical device	Select Self Functioning Home use Clinical Use Home and Clinical Use Combination with other medical device
Medical Device packed*	Select Sterile Non Sterile Others
Medical Device Tested as per	Select Not Tested IEC 60601-1 IEC 60601-1 + ISO 10993-1 ISO 10993-1 Device Specific Testing
4. SUBMITTER INFORMATION
Contact Person* Select Mr Mrs Dr Prof Ms
Job Title*
Contact Number*
Contact Email*