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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 K813341
Device Name WOUND-EVAC
Applicant
HERITAGE MEDICAL PRODUCTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HERITAGE MEDICAL PRODUCTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4680
Classification Product Code
GCY  
Date Received11/25/1981
Decision Date 12/18/1981
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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