The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Silver Foam Wound Dressing.
Device ID | K914579 |
510k Number | K914579 |
Device Name: | SILVER FOAM WOUND DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | VITAPHORE CORP. 1505 O'BRIEN DR. Menlo Park, CA 94025 |
Contact | Sophia Pesotchinsky |
Correspondent | Sophia Pesotchinsky VITAPHORE CORP. 1505 O'BRIEN DR. Menlo Park, CA 94025 |
Product Code | MGP |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-16 |
Decision Date | 1992-02-21 |