The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Rg27-series Resectoscope And Accessories.
| Device ID | K914108 |
| 510k Number | K914108 |
| Device Name: | RG27-SERIES RESECTOSCOPE AND ACCESSORIES |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-13 |
| Decision Date | 1992-03-19 |