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FDA 510(k) Application Details - K070402
Device Classification Name
Pack, Hot Or Cold, Water Circulating
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5720
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Classification Product Code
ILO
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More FDA Info for this Product Code
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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