FDA 510(k) Application Details - K093951

Device Classification Name Refrigerant, Topical (Vapocoolant)

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510(K) Number K093951
Device Name Refrigerant, Topical (Vapocoolant)
Applicant OCCAM DESIGN
1044 EAST CHESTNUT ST.
LOUISVILLE, KY 40204 US
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Contact VAS ABRAMOV
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Regulation Number 000.0000

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Classification Product Code MLY
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Date Received 12/23/2009
Decision Date 06/15/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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