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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 K790389
Device Name GAUZE & COTTON SPONGES
Applicant
MEDTECH INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDTECH INTL., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4450
Classification Product Code
GDY  
Date Received02/26/1979
Decision Date 03/26/1979
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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