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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 K874645
Device Name CLOSED WOUND DRAINAGE SYSTEMS
Applicant
HALL LABORATORIES, INC.
9900 CAMINO ROYAL #91
MERRIAM,  KS  66203
Applicant Contact JOHN E HALL
Correspondent
HALL LABORATORIES, INC.
9900 CAMINO ROYAL #91
MERRIAM,  KS  66203
Correspondent Contact JOHN E HALL
Regulation Number878.4680
Classification Product Code
GCY  
Date Received11/13/1987
Decision Date 12/02/1987
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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