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510(k) K033720

ARI COLD SPRAY by Ari — Product Code MLY

K033720 is an FDA 510(k) premarket notification submitted by Ari for the device "ARI COLD SPRAY". The FDA issued a decision of Substantially Equivalent on June 10, 2005. The device falls under product code MLY (Vapocoolant Device), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2005
Date Received
November 26, 2003
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