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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K983719
Device Name BIOSHIELD EXPRESS STERILIZATION WRAP
Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK,  IL  60085
Applicant Contact PATRICIA SHARPE-GREGG
Correspondent
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK,  IL  60085
Correspondent Contact PATRICIA SHARPE-GREGG
Regulation Number880.6850
Classification Product Code
FRG  
Date Received10/21/1998
Decision Date 08/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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