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510(k) K992286

DERMAFREEZE by Rhealm Pharmaceuticals, Inc. — Product Code MLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2000
Date Received
July 7, 1999
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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