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FDA 510(k) Application Details - K030281
Device Classification Name
Refrigerant, Topical (Vapocoolant)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MLY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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