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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 K120947
Device Name THS INSTRUMENT TRAY
Applicant
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Applicant Contact SARAH FAIRFIELD
Correspondent
Hologic, Inc.
250 Campus Dr.
Malborough,  MA  01752
Correspondent Contact SARAH FAIRFIELD
Regulation Number880.6850
Classification Product Code
KCT  
Date Received03/29/2012
Decision Date 10/17/2012
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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