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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K922878
Device Name MODEL GT1ST CRYOSURGICAL INSTRUMENT
Applicant
Gyne-Tech Instrument Corp.
1111 Chestnut St.
Burbank,  CA  91506
Applicant Contact KERMIT FLOYD
Correspondent
Gyne-Tech Instrument Corp.
1111 Chestnut St.
Burbank,  CA  91506
Correspondent Contact KERMIT FLOYD
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/15/1992
Decision Date 09/02/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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