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FDA 510(k) Application Details - K181845
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K181845
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
RP Medical, Inc.
22715 Holyrood Avenue
Maple Ridge V2X 6E7 CA
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Contact
Jim Barley
Other 510(k) Applications for this Contact
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
07/11/2018
Decision Date
11/25/2019
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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