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FDA 510(k) Application Details - K110867
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
880.6850
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Classification Product Code
FRG
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More FDA Info for this Product Code
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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