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FDA 510(k) Application Details - K982652
Device Classification Name
Pack, Hot Or Cold, Disposable
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510(K) Number
K982652
Device Name
Pack, Hot Or Cold, Disposable
Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 WAUKEGAN RD.- K
MCGRAW PARK, IL 60085 US
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Contact
PATRICIA SHARPE-GREGG
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Regulation Number
890.5710
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Classification Product Code
IMD
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More FDA Info for this Product Code
Date Received
07/30/1998
Decision Date
01/21/1999
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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