FDA 510(k) Application Details - K110867

Device Classification Name Wrap, Sterilization

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510(K) Number K110867
Device Name Wrap, Sterilization
Applicant CPAC, INC.
2364 LEICESTER RD.
P.O. BOX 175
LEICESTER, NY 14481-0175 US
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Contact JEFFREY S CRANE
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 03/29/2011
Decision Date 07/20/2011
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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