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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K061933
Device Name HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER
Applicant
Hager Worldwide, Inc.
4 Lincoln St.
Andover,  MA  01810
Applicant Contact JAMES DELANEY
Correspondent
Hager Worldwide, Inc.
4 Lincoln St.
Andover,  MA  01810
Correspondent Contact JAMES DELANEY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/07/2006
Decision Date 11/16/2006
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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