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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, rigid
510(k) Number K931954
Device Name THORACOSCOPE/LAPAROSCOPE
Applicant
SURGICAL TECHNOLOGIES, INC.
4715 N.W. 157TH ST., SUITE 212
MIAMI LAKES,  FL  33014
Applicant Contact LASZLO FAZEKAS
Correspondent
SURGICAL TECHNOLOGIES, INC.
4715 N.W. 157TH ST., SUITE 212
MIAMI LAKES,  FL  33014
Correspondent Contact LASZLO FAZEKAS
Regulation Number876.1500
Classification Product Code
GCM  
Date Received04/20/1993
Decision Date 11/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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