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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 K990584
Device Name GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
Applicant
Broadline Medical Industries
1432 Shire Cir.
Inverness,  IL  60067
Applicant Contact ANNA M RAMZA
Correspondent
Broadline Medical Industries
1432 Shire Cir.
Inverness,  IL  60067
Correspondent Contact ANNA M RAMZA
Classification Product Code
EFQ  
Subsequent Product Code
GDY  
Date Received02/23/1999
Decision Date 04/23/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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