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FDA 510(k) Application Details - K170848
Device Classification Name
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
More FDA Info for this Device
510(K) Number
K170848
Device Name
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Applicant
Nasaleze International Ltd
Old Castletown Road
Douglas Im2 1qa IM
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Contact
Matt Duxbury
Other 510(k) Applications for this Contact
Regulation Number
880.5045
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Classification Product Code
NUP
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More FDA Info for this Product Code
Date Received
03/21/2017
Decision Date
06/14/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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