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510(k) K172598

Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE by Itw Contamination Control Electronics — Product Code MLY

K172598 is an FDA 510(k) premarket notification submitted by Itw Contamination Control Electronics for the device "Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE". The FDA issued a decision of Substantially Equivalent on April 19, 2018. The device falls under product code MLY (Vapocoolant Device), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2018
Date Received
August 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vapocoolant Device
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

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FDA data resources