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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K894064
Device Name STERILE HAND COVER
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
LYU  
Date Received06/08/1989
Decision Date 08/11/1989
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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