The following data is part of a premarket notification filed by Gyne-tech Instrument Corp. with the FDA for Model Gt1st Cryosurgical Instrument.
| Device ID | K922878 |
| 510k Number | K922878 |
| Device Name: | MODEL GT1ST CRYOSURGICAL INSTRUMENT |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | GYNE-TECH INSTRUMENT CORP. 1111 CHESTNUT ST. Burbank, CA 91506 |
| Contact | Kermit Floyd |
| Correspondent | Kermit Floyd GYNE-TECH INSTRUMENT CORP. 1111 CHESTNUT ST. Burbank, CA 91506 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-15 |
| Decision Date | 1992-09-02 |