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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K980490
Device Name SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
Applicant
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014
Applicant Contact CHRISTINE FALKSTROM
Correspondent
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014
Correspondent Contact CHRISTINE FALKSTROM
Regulation Number880.5570
Classification Product Code
MMK  
Date Received02/09/1998
Decision Date 02/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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