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FDA 510(k) Application Details - K032671
Device Classification Name
Refrigerant, Topical (Vapocoolant)
More FDA Info for this Device
510(K) Number
K032671
Device Name
Refrigerant, Topical (Vapocoolant)
Applicant
GEBAUER CO.
9410 ST. CATHERINE AVE.
CLEVELAND, OH 44104 US
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Contact
AMY J PAUKOVITS
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MLY
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More FDA Info for this Product Code
Date Received
08/29/2003
Decision Date
03/17/2004
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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