The following data is part of a premarket notification filed by Progressive Surgical Products, Inc. with the FDA for Proxiderm (d-460,d 90 460,d 180,460, Ps 460).
Device ID | K970439 |
510k Number | K970439 |
Device Name: | PROXIDERM (D-460,D 90 460,D 180,460, PS 460) |
Classification | System, Skin Closure |
Applicant | PROGRESSIVE SURGICAL PRODUCTS, INC. 694 MAIN ST. Westbury, NY 11590 |
Contact | Robert Oddson |
Correspondent | Robert Oddson 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 | 1997-02-05 |
Decision Date | 1997-04-16 |