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510(k) K112547

NEO NEST by Denovo Proucts, LLC — Product Code IMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2012
Date Received
September 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

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