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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystourethroscope
510(k) Number K941992
Device Name CYSTOSCOPE
Applicant
Surgical Technologies, Inc.
4715 NW 157th. St.,
Suite 124
Miami Lakes,  FL  33014
Applicant Contact LASZLO FAZEKAS
Correspondent
Surgical Technologies, Inc.
4715 NW 157th. St.,
Suite 124
Miami Lakes,  FL  33014
Correspondent Contact LASZLO FAZEKAS
Regulation Number876.1500
Classification Product Code
FBO  
Date Received04/25/1994
Decision Date 11/30/1995
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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