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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K020593
Device Name CONVERTORS SMS POLYOLEFIN GOWN
Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD. MPWM-1E
MCGAW PARK,  IL  60085
Applicant Contact SHARON ROBBINS
Correspondent
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD. MPWM-1E
MCGAW PARK,  IL  60085
Correspondent Contact SHARON ROBBINS
Regulation Number878.4040
Classification Product Code
FYA  
Date Received02/22/2002
Decision Date 03/18/2002
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
Recalls CDRH Recalls
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