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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 K944309
Device Name M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM
Applicant
M.E.R. SURGICAL CO.
773 TROTTER COURT
WALNUT,  CA  91789
Applicant Contact WILLIAM MEYER
Correspondent
M.E.R. SURGICAL CO.
773 TROTTER COURT
WALNUT,  CA  91789
Correspondent Contact WILLIAM MEYER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/02/1994
Decision Date 04/03/1995
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
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