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FDA 510(k) Application Details - K962983
Device Classification Name
Pack, Hot Or Cold, Water Circulating
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510(K) Number
K962983
Device Name
Pack, Hot Or Cold, Water Circulating
Applicant
ADROIT MEDICAL SYSTEMS, INC.
1146 CARDING MACHINE RD.
LOUDON, TN 37774 US
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Contact
RICHARD L STRUDER
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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
08/01/1996
Decision Date
01/10/1997
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
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