FDA 510(k) Application Details - K992286

Device Classification Name Refrigerant, Topical (Vapocoolant)

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510(K) Number K992286
Device Name Refrigerant, Topical (Vapocoolant)
Applicant RHEALM PHARMACEUTICALS, INC.
258 SE 6TH AVE., SUITE 12
DELRAY BEACH, FL 33483 US
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Contact RICHARD MANN
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Regulation Number 000.0000

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Classification Product Code MLY
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Date Received 07/07/1999
Decision Date 01/21/2000
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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