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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
510(k) Number K991757
Device Name NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
Applicant
Furlong Industries
311 N. Slusser St.
Grayslake,  IL  60030
Applicant Contact PETE FURLONG
Correspondent
Furlong Industries
311 N. Slusser St.
Grayslake,  IL  60030
Correspondent Contact PETE FURLONG
Classification Product Code
EFQ  
Date Received05/24/1999
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
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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