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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 K803188
Device Name GAUZE SPONGES
Applicant
ABCO DEALERS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ABCO DEALERS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4450
Classification Product Code
GDY  
Date Received12/16/1980
Decision Date 01/15/1981
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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