The following data is part of a premarket notification filed by Circon Corp. with the FDA for Transvaginal Hydro Laparoscopy (thl) System.
| Device ID | K992544 |
| 510k Number | K992544 |
| Device Name: | TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | CIRCON CORP. 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen CIRCON CORP. 6500 HOLLISTER AVE. Santa Barbara, CA 93117 -3019 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-30 |
| Decision Date | 1999-10-26 |
| Summary: | summary |