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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 K884335
Device Name GAUZE BANDAGE 4 X 6 YDS.
Applicant
North Health Care
1515 Elmwood Rd.
Rockford,  IL  61103
Applicant Contact JAMES WRIGHT
Correspondent
North Health Care
1515 Elmwood Rd.
Rockford,  IL  61103
Correspondent Contact JAMES WRIGHT
Regulation Number878.4014
Classification Product Code
NAB  
Date Received10/14/1988
Decision Date 01/09/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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