The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion Mogen Clamp/circumcision (ster/non Ster).
| Device ID | K935491 |
| 510k Number | K935491 |
| Device Name: | CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) |
| Classification | Clamp, Circumcision |
| Applicant | TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. Howell, MI 48843 |
| Contact | George J Pluta |
| Correspondent | George J Pluta TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. Howell, MI 48843 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-15 |
| Decision Date | 1994-02-17 |