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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 K023425
Device Name DRAPES WITH ABSORBENT REINFORCEMENT
Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD. MPWM-1E
MCGAW PARK,  IL  60085
Applicant Contact SHARON NICHOLS
Correspondent
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD. MPWM-1E
MCGAW PARK,  IL  60085
Correspondent Contact SHARON NICHOLS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/11/2002
Decision Date 11/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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