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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophagoscope (Flexible Or Rigid)
510(k) Number K951424
Device Name M. E. R. SURGICAL CO. OMIN 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 Number874.4710
Classification Product Code
EOX  
Subsequent Product Codes
EOB   EOQ  
Date Received03/27/1995
Decision Date 05/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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