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510(k) K123910

WOUNDWASH SALINE SPRAY by Neilmed Pharmaceuticals, Inc. — Product Code FRO

K123910 is an FDA 510(k) premarket notification submitted by Neilmed Pharmaceuticals, Inc. for the device "WOUNDWASH SALINE SPRAY". The FDA issued a decision of Substantially Equivalent on October 29, 2013. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2013
Date Received
December 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources