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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K982369
Device Name CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
Applicant
Allegiance Healthcare Corp.
1500 Waukegan Rd.- K
Mcgraw Park,  IL  60085
Applicant Contact SHARON ROBBINS
Correspondent
Allegiance Healthcare Corp.
1500 Waukegan Rd.- K
Mcgraw Park,  IL  60085
Correspondent Contact SHARON ROBBINS
Regulation Number878.4040
Classification Product Code
FYC  
Date Received07/07/1998
Decision Date 08/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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