REQUEST FOR FDA 510K PROPOSAL

Please fill out the FDA 510k request for proposal and submit it online for a comprehensive proposal. It’s crucial to realize that the precise and accurate information provided here will aid us in accurately estimating the budget.

1. MANUFACTURER INFORMATION

Legal Manufacturer / Specification Developer Name *:
Street *:
City / Pincode *:
Country *:
Website Address :

2. ADMINISTRATIVE INFORMATION

Role of the 510k applicant

Status of GMP :

3. MEDICAL DEVICE DESCRIPTION

Name of the Medical Device *:
FDA Product Code(s) [ ? ] *:
FDA Regulation Number(s) :
Predicative Device 510k Number(s)[ ? ] *:
Device Class *:
Intended use of the device [ ? ]:


Device Brand Name / Trade Name :
Number of Models [ ? ] *:
Difference between the Models :
Device Body Contact *:
Device Invasive action by :
Type of Medical device :
Medical Device packed *:
Medical Device Tested as per :


4. SUBMITTER INFORMATION

Contact Person * :

Job Title * :

Contact Number *:

Contact Email *: