The following data is part of a premarket notification filed by Progressive Surgical Products, Inc. with the FDA for Proxiderm, Models Tn 460, Tn 90 460, Bk 460.
| Device ID | K982439 |
| 510k Number | K982439 |
| Device Name: | PROXIDERM, MODELS TN 460, TN 90 460, BK 460 |
| Classification | System, Skin Closure |
| Applicant | PROGRESSIVE SURGICAL PRODUCTS, INC. 89 GARDEN ST. Westbury, NY 11590 |
| Contact | Robert Oddsen |
| Correspondent | Robert Oddsen PROGRESSIVE SURGICAL PRODUCTS, INC. 89 GARDEN 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 | 1998-07-14 |
| Decision Date | 1998-09-08 |