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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K121280
Device Name MYOSURE INTRUMENT TRAY
Applicant
Hologic, Inc.
250 Campus Dr.
Marlborough,  MA  01752
Applicant Contact DANIEL F PHELAN
Correspondent
Hologic, Inc.
250 Campus Dr.
Marlborough,  MA  01752
Correspondent Contact DANIEL F PHELAN
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/30/2012
Decision Date 02/08/2013
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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