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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 K844786
Device Name NURSES & SURGEONS CAPS, ISOLATION GOWNS-FIRE RETAR
Applicant
Durawear
18210 Sherman Way, Wuite 111
Reseda,  CA  91335
Applicant Contact ERWIN B GAINES
Correspondent
Durawear
18210 Sherman Way, Wuite 111
Reseda,  CA  91335
Correspondent Contact ERWIN B GAINES
Regulation Number878.4040
Classification Product Code
FYC  
Date Received12/10/1984
Decision Date 01/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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