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FDA 510(k) Application Details - K955057
Device Classification Name
Pack, Hot Or Cold, Water Circulating
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510(K) Number
K955057
Device Name
Pack, Hot Or Cold, Water Circulating
Applicant
SMITH AND NEPHEW DONJOY, INC.
2777 LOKER AVENUE WEST
CARSBAD, CA 92008-6601 US
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Contact
DAN W MILLER
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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
11/06/1995
Decision Date
03/08/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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