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FDA 510(k) Application Details - K094026
Device Classification Name
Sterilizer, Dry Heat
More FDA Info for this Device
510(K) Number
K094026
Device Name
Sterilizer, Dry Heat
Applicant
CPAC, INC.
2364 LEICESTER RD.
P.O. BOX 175
LEICESTER, NY 14481-0175 US
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Contact
JEFFREY CRANE
Other 510(k) Applications for this Contact
Regulation Number
880.6870
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Classification Product Code
KMH
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More FDA Info for this Product Code
Date Received
12/30/2009
Decision Date
07/12/2011
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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