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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name scalpel, one-piece
510(k) Number K853103
Device Name MCKNIFE
Applicant
MEDICAL DIMENSIONS
44 VILLAGE PARK WAY
SANTA MONICA,  CA  90405
Applicant Contact JOHN B MCADAMS
Correspondent
MEDICAL DIMENSIONS
44 VILLAGE PARK WAY
SANTA MONICA,  CA  90405
Correspondent Contact JOHN B MCADAMS
Regulation Number878.4800
Classification Product Code
GDX  
Date Received07/23/1985
Decision Date 08/06/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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