The following data is part of a premarket notification filed by Gyne-tech Instrument Corp. with the FDA for Omega Ultrascan.
| Device ID | K954911 |
| 510k Number | K954911 |
| Device Name: | OMEGA ULTRASCAN |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GYNE-TECH INSTRUMENT CORP. 2819 BURTON ST. Burbank, CA 91504 |
| Contact | J. Kermit Floyd |
| Correspondent | J. Kermit Floyd GYNE-TECH INSTRUMENT CORP. 2819 BURTON ST. Burbank, CA 91504 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-25 |
| Decision Date | 1996-01-24 |