The following data is part of a premarket notification filed by Conceptus, Inc. with the FDA for Conceptus Fallopian Tube Catheteization With Microendoscopy System.
| Device ID | K962587 |
| 510k Number | K962587 |
| Device Name: | CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM |
| Classification | Falloposcope |
| Applicant | CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Contact | Nancy Naddaff |
| Correspondent | Nancy Naddaff CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Product Code | MKO |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-01 |
| Decision Date | 1997-01-31 |
| Summary: | summary |