The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion(r) Site Guard(r) Transparent Dressing/transpaent Film Dressing.
| Device ID | K945977 |
| 510k Number | K945977 |
| Device Name: | CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| 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 | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1995-03-29 |