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FDA 510(k) Application Details - K141826
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K141826
Device Name
Wrap, Sterilization
Applicant
SYMMETRY MEDICAL INC- MANCHESTER
253 ABBY ROAD
MANCHESTER, NH 03103 US
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Contact
ROBERT JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/07/2014
Decision Date
04/02/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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