The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Copolyester Film Dressing.
| Device ID | K893647 |
| 510k Number | K893647 |
| Device Name: | COPOLYESTER FILM DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell, MI 48843 |
| Contact | George J Pluta |
| Correspondent | George J Pluta TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. P.O. BOX 170 Howell, MI 48843 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-10-16 |