510(k) K131692

BLOSSOM SALINE DELIVERY ASSIST DEVICE by Marz Medical, Inc. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2014
Date Received
June 10, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type