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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 K954911
Device Name OMEGA ULTRASCAN
Applicant
Gyne-Tech Instrument Corp.
2819 Burton St.
Burbank,  CA  91504
Applicant Contact J. KERMIT FLOYD
Correspondent
Gyne-Tech Instrument Corp.
2819 Burton St.
Burbank,  CA  91504
Correspondent Contact J. KERMIT FLOYD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/25/1995
Decision Date 01/24/1996
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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