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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 K002419
Device Name SURGICAL DRAPES
Applicant
ALLEGIANCE HEALTHCARE COPORATION
1500 WAUKERGAN RD.
MCGAW PARK,  IL  60085
Applicant Contact SHARON ROBBINS
Correspondent
ALLEGIANCE HEALTHCARE COPORATION
1500 WAUKERGAN RD.
MCGAW PARK,  IL  60085
Correspondent Contact SHARON ROBBINS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/08/2000
Decision Date 08/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
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