The following data is part of a premarket notification filed by Conceptus, Inc. with the FDA for Hysteroscope.
| Device ID | K954164 |
| 510k Number | K954164 |
| Device Name: | HYSTEROSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1996-03-12 |
| Summary: | summary |