The following data is part of a premarket notification filed by Progressive Surgical Products, Inc. with the FDA for Proxiderm (tentative).
Device ID | K942425 |
510k Number | K942425 |
Device Name: | PROXIDERM (TENTATIVE) |
Classification | System, Skin Closure |
Applicant | PROGRESSIVE SURGICAL PRODUCTS, INC. 694 MAIN ST. Westbury, NY 11590 |
Contact | Robert Oddsen |
Correspondent | Robert Oddsen PROGRESSIVE SURGICAL PRODUCTS, INC. 694 MAIN ST. Westbury, NY 11590 |
Product Code | MKY |
CFR Regulation Number | 878.4320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-20 |
Decision Date | 1994-11-04 |