FDA 510(k) Application Details - K032671

Device Classification Name Refrigerant, Topical (Vapocoolant)

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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
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Regulation Number 000.0000

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Classification Product Code MLY
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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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