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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 K943491
Device Name RIGHT ANGLE UROLOGIC LASER FIBER
Applicant
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Applicant Contact BRIAN KUNST
Correspondent
Surgitek
3037 Mt. Pleasant St.
Racine,  WI  53404
Correspondent Contact BRIAN KUNST
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/19/1994
Decision Date 08/05/1994
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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