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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,Nonresorbable For External Use
510(k) Number K780795
Device Name GAUZE SPONGES
Applicant
Abco Dealers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Abco Dealers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4014
Classification Product Code
NAB  
Date Received05/15/1978
Decision Date 06/06/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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