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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Sponge, Surgical
510(k) Number K972302
Device Name POCKET COUNT OR SAFETCOUNT
Applicant
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014 -8172
Applicant Contact KAREN PINTO
Correspondent
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014 -8172
Correspondent Contact KAREN PINTO
Regulation Number880.2740
Classification Product Code
LWH  
Date Received06/19/1997
Decision Date 07/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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