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FDA 510(k) Application Details - K110898
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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510(K) Number
K110898
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
AMMED SURGICAL EQUIPMENT, LLC
8708 CAPEHART COVE
AUSTIN, TX 78733 US
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Contact
DAVID C FURR
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Regulation Number
880.6850
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Classification Product Code
KCT
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More FDA Info for this Product Code
Date Received
03/30/2011
Decision Date
07/26/2012
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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