The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion Circlamp.
| Device ID | K890897 |
| 510k Number | K890897 |
| Device Name: | CENTURION CIRCLAMP |
| Classification | Clamp, Circumcision |
| 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 | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-22 |
| Decision Date | 1989-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653160221210 | K890897 | 000 |
| 10653160181231 | K890897 | 000 |
| 10653160197447 | K890897 | 000 |
| 10653160197454 | K890897 | 000 |
| 10653160197461 | K890897 | 000 |
| 10653160197478 | K890897 | 000 |
| 10653160197485 | K890897 | 000 |
| 10653160197492 | K890897 | 000 |
| 10653160197508 | K890897 | 000 |
| 00653160278132 | K890897 | 000 |
| 00653160309898 | K890897 | 000 |
| 00653160309904 | K890897 | 000 |
| 00653160312898 | K890897 | 000 |
| 00653160312904 | K890897 | 000 |
| 00653160312935 | K890897 | 000 |
| 00653160312942 | K890897 | 000 |
| 00653160312959 | K890897 | 000 |
| 10653160181224 | K890897 | 000 |