FDA 510(k) Application Details - K030281

Device Classification Name Refrigerant, Topical (Vapocoolant)

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510(K) Number K030281
Device Name Refrigerant, Topical (Vapocoolant)
Applicant CRYONIC MEDICAL NORTH AMERICA
1350 DANIELSON RD.
MONTECITO, CA 93108 US
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Contact SANDRA WILLIAMSON
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Regulation Number 000.0000

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Classification Product Code MLY
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Date Received 01/27/2003
Decision Date 08/20/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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