The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion Vaginal Speculum.
| Device ID | K897100 |
| 510k Number | K897100 |
| Device Name: | CENTURION VAGINAL SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal, Fiberoptic |
| 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 | HIC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-21 |
| Decision Date | 1990-03-16 |