Medical Device 510 (k) Submission
we have a medical device, and we are working on our 510k submission. For the fda we need some performance testing/verification testing.
Please let me know if you have experience in working with x ray dental sensors and we would love to work with you.
Thanks,+10 Other Responses
i represent *************medical engineering pvt. Ltd., mumbai india.George philips was established in 1995 and today, is one of india's leading manufacturer and supplier of 'life saving medical devices and disposables' to the healthcare industry, both domestically and internationally.
I am writing to express my interest in seeking your assistance for the submission of 2 of our products (iv flow regulator and disposable pressure transducer kit) for 510 k approval.Kindly provide a quote for processing our application.
Awaiting your reply at the earliest.+12 Other Responses
Interested in filing a 510(k) clearance or class 1 filing for radio frequency and aesthetic system, we already have catalog. Interested in flat rate, need proposal, we just became premium member, would like a 15-30 minute conversation prior to contrating.+10 Other Responses
510(k) Premarket Notification
I am looking for someone that can help me perform a temperature over time test. I am working on a wart removal product and it requires that the applicators drop in temperature to an effective temperature rate of -50c with the chemical blend in a canister (liquid gas blend acting as a cryogen). A written report has to be prepared showing the protocols and the results of the test. Hopefully with some photographs of the devices tested. It will be two devices. This is being prepared for submission to the fda for a 510(k) premarket notification. Let me know if this is something you are familiar with.+3 Other Responses