The following data is part of a premarket notification filed by Gynecare, A Div. Of Ethicon, Inc. with the FDA for Versapoint Resectoscopic System.
| Device ID | K040302 |
| 510k Number | K040302 |
| Device Name: | VERSAPOINT RESECTOSCOPIC SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GYNECARE, A DIV. OF ETHICON, INC. U.S. ROUTE 22 WEST P.O.BOX 151 Somerville, NJ 08876 |
| Contact | Patricia M Hojnoski |
| Correspondent | Patricia M Hojnoski GYNECARE, A DIV. OF ETHICON, INC. U.S. ROUTE 22 WEST P.O.BOX 151 Somerville, NJ 08876 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-03-09 |
| Summary: | summary |