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FDA 510(k) Application Details - K242834
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K242834
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
Stryker Instruments
1941 Stryker Way
Portage, MI 49002 US
Other 510(k) Applications for this Company
Contact
Megan Guilbault
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
KCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2024
Decision Date
01/16/2025
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
FDA Source Information for K242834
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