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FDA 510(k) Application Details - K082087
Device Classification Name
Pack, Hot Or Cold, Disposable
More FDA Info for this Device
510(K) Number
K082087
Device Name
Pack, Hot Or Cold, Disposable
Applicant
BIO-LIPID, INC.
1700 PENNSYLVANIA AVE., NW
WASHINGTON, DC 20006 US
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Contact
PAMELA FURMAN
Other 510(k) Applications for this Contact
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
07/23/2008
Decision Date
09/11/2008
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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