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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, suction, single patient use, portable, nonpowered
510(k) Number K850037
Device Name CLOSED WOUND DRAIN
Applicant
CONSOLIDATED MEDICAL EQUIPMENT, INC.
310 BROAD ST.
UTICA,  NY  13501
Applicant Contact WILLIAM W ABRAHAM
Correspondent
CONSOLIDATED MEDICAL EQUIPMENT, INC.
310 BROAD ST.
UTICA,  NY  13501
Correspondent Contact WILLIAM W ABRAHAM
Regulation Number878.4680
Classification Product Code
GCY  
Date Received01/07/1985
Decision Date 03/19/1985
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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