FDA 510(k) Application Details - K040317

Device Classification Name Pack, Hot Or Cold, Water Circulating

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510(K) Number K040317
Device Name Pack, Hot Or Cold, Water Circulating
Applicant MARK H. FRIEDMAN
2 OVERHILL RD., STE 260
SCARSDALE, NY 10583 US
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Contact MARK H FRIEDMAN
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Regulation Number 890.5720

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Classification Product Code ILO
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Date Received 02/09/2004
Decision Date 05/07/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K040317


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