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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, surgical instrument, disposable
510(k) Number K813103
Device Name ACKRAD INCISION & DRAIN SET
Applicant
ACKRAD LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ACKRAD LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
KDD  
Date Received11/03/1981
Decision Date 12/09/1981
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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