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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dilator, nasal
510(k) Number K982929
Device Name MAXAIR NASAL DILATOR SYSTEM
Applicant
HNL TECHNOLOGIES
2222 ALAMEDA DE LAS PULGAS
SAN MATEO,  CA  94403
Applicant Contact HANFORD N LOCKWOOD, JR.
Correspondent
HNL TECHNOLOGIES
2222 ALAMEDA DE LAS PULGAS
SAN MATEO,  CA  94403
Correspondent Contact HANFORD N LOCKWOOD, JR.
Regulation Number874.3900
Classification Product Code
LWF  
Date Received08/20/1998
Decision Date 09/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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