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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 K874888
Device Name ISOLATION GOWN
Applicant
Sage Products, Inc.
680 Industrial Dr.
Cary,  IL  60013
Applicant Contact PAUL HANIFL
Correspondent
Sage Products, Inc.
680 Industrial Dr.
Cary,  IL  60013
Correspondent Contact PAUL HANIFL
Regulation Number878.4040
Classification Product Code
FYC  
Date Received12/01/1987
Decision Date 12/30/1987
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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