FDA 510(k) Application Details - K070402

Device Classification Name Pack, Hot Or Cold, Water Circulating

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510(K) Number K070402
Device Name Pack, Hot Or Cold, Water Circulating
Applicant BREG, INC.
2611 COMMERCE WAY
VISTA, CA 92083 US
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Contact KATHLEEN BARBER
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Regulation Number 890.5720

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Classification Product Code ILO
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Date Received 02/12/2007
Decision Date 03/29/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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