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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gouge, surgical, general & plastic surgery
510(k) Number K760850
Device Name PARKES HUMP GAUGE STRAIGHT 7" (18 CM)
Original Applicant
V. MUELLER O.V. BAXTER HEALTHCARE CORP.
Regulation Number878.4800
Classification Product Code
GDH  
Date Received10/15/1976
Decision Date 11/03/1976
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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