The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion Disposable Instruments.
| Device ID | K923812 |
| 510k Number | K923812 |
| Device Name: | CENTURION DISPOSABLE INSTRUMENTS |
| Classification | Instrument, Manual, Surgical, General Use |
| 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 | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-29 |
| Decision Date | 1992-12-17 |