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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K991667
Device Name BROADLINE OR TOWELS
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
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/14/1999
Decision Date 09/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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