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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 K881012
Device Name WOUND-EVAC RS
Applicant
HERITAGE MEDICAL PRODUCTS
P.O. BOX 1147
TUCKER,  GA  30085
Applicant Contact GREGORY SMALLWOOD
Correspondent
HERITAGE MEDICAL PRODUCTS
P.O. BOX 1147
TUCKER,  GA  30085
Correspondent Contact GREGORY SMALLWOOD
Regulation Number878.4680
Classification Product Code
GCY  
Date Received03/10/1988
Decision Date 03/17/1988
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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