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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K964168
Device Name PROCEDURE SPECIFIC KITS
Applicant
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014
Applicant Contact KAREN PINTO
Correspondent
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014
Correspondent Contact KAREN PINTO
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/17/1996
Decision Date 03/03/1997
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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