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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gauze/sponge, internal, x-ray detectable
510(k) Number K853742
Device Name GAUZE SPONGE
Applicant
SOUTH MOUNTAIN MEDICAL
537 SWEETEN CK. INC. PK
ASHEVILLE,  NC  28803
Applicant Contact CLAIRE BRANCH
Correspondent
SOUTH MOUNTAIN MEDICAL
537 SWEETEN CK. INC. PK
ASHEVILLE,  NC  28803
Correspondent Contact CLAIRE BRANCH
Regulation Number878.4450
Classification Product Code
GDY  
Date Received09/06/1985
Decision Date 10/08/1985
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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