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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K935207
Device Name ENDOFLUSH SYSTEM 1.0, 2.O, 3.0
Applicant
Specialty Medical Systems, Inc.
P.O.Box 16598
Fort Worth,  TX  76162 -0598
Applicant Contact RICHARD A HAMER
Correspondent
Specialty Medical Systems, Inc.
P.O.Box 16598
Fort Worth,  TX  76162 -0598
Correspondent Contact RICHARD A HAMER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/29/1993
Decision Date 04/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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