FDA 510(k) Application Details - K982929

Device Classification Name Dilator, Nasal

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510(K) Number K982929
Device Name Dilator, Nasal
Applicant HNL TECHNOLOGIES
2222 ALAMEDA DE LAS PULGAS
SAN MATEO, CA 94403 US
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Contact HANFORD N LOCKWOOD, JR.
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Regulation Number 874.3900

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Classification Product Code LWF
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Date Received 08/20/1998
Decision Date 09/09/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K982929


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