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510(k) K093951

OUCHLESS MODEL PN10114 by Occam Design — Product Code MLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2010
Date Received
December 23, 2009
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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