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FDA 510(k) Application Details - K161415
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K161415
Device Name
Wrap, Sterilization
Applicant
CASE MEDICAL, INC.
19 EMPIRE BLVD.
SOUTH HACKENSACK, NJ 07606 US
Other 510(k) Applications for this Company
Contact
TANIA LUPU
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/23/2016
Decision Date
02/10/2017
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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