FDA 510(k) Application Details - K141826

Device Classification Name Wrap, Sterilization

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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
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Regulation Number 880.6850

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Classification Product Code FRG
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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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