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FDA 510(k) Application Details - K052567
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K052567
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
STERILE CONTAINMENT TECHNOLOGY, LLC.
1301 QUARRY COURT, SUITE 204
POINT RICHMOND, CA 94801 US
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Contact
GAGE GARMAN
Other 510(k) Applications for this Contact
Regulation Number
880.6850
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Classification Product Code
KCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2005
Decision Date
03/13/2006
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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