The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Diagnostic Hysteroscopy Redikit (tm).
| Device ID | K910254 |
| 510k Number | K910254 |
| Device Name: | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) |
| Classification | Cup, Menstrual |
| Applicant | COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-04-18 |