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FDA 510(k) Application Details - K181933
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K181933
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
Synthes (USA) Products LLC / DePuy Orthopaedics Inc.
1301 Goshen Parkway
West Chester, PA 19380 US
Other 510(k) Applications for this Company
Contact
Thomas Shea
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
07/19/2018
Decision Date
05/09/2019
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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