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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wrap, sterilization
510(k) Number K113776
Device Name FLASHPAK
Applicant
SYMMETRY MEDICAL
61 JOHN VERTENTE BLVD
NEW BEDFORD,  MA  02745
Applicant Contact ROBERT JOHNSON
Correspondent
SYMMETRY MEDICAL
61 JOHN VERTENTE BLVD
NEW BEDFORD,  MA  02745
Correspondent Contact ROBERT JOHNSON
Regulation Number880.6850
Classification Product Code
FRG  
Date Received12/22/2011
Decision Date 08/08/2012
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
Recalls CDRH Recalls
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