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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope
510(k) Number K936038
Device Name SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)
Applicant
Surgical Laser Technologies, Inc.
200 Cresson Blvd.
P.O.Box 880
Oaks,  PA  19456 -0880
Applicant Contact THOMAS BECZE
Correspondent
Surgical Laser Technologies, Inc.
200 Cresson Blvd.
P.O.Box 880
Oaks,  PA  19456 -0880
Correspondent Contact THOMAS BECZE
Regulation Number876.1500
Classification Product Code
FJL  
Date Received12/20/1993
Decision Date 05/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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