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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) Number K895774
Device Name GYN-PROBE
Original Applicant
1311 valencia ave.
tustin,  CA  92680
Original Contact merritt m girgis
Regulation Number878.4810
Classification Product Code
Date Received09/26/1989
Decision Date 01/03/1990
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