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510(k) K982929

Device
Maxair Nasal Dilator System
Applicant
HNL TECHNOLOGIES
510(k) number
K982929
Product code
LWF
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-09
Date received
1998-08-20
Regulation
874.3900
Classification name
Dilator, Nasal
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HANFORD N LOCKWOOD, JR.
Address
2222 Alameda De Las Pulgas San Mateo CA US 94403 94403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LWF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181219OptiPillows EPAP MaskCpapnea Medical Supply2018-08-03
K120665INVENT SNORING DEVICEVentus Medical, Inc.2012-06-12
K040491CHIN-UP STRIPDale Miller, Inc. - the Chin-Up Company2004-09-10
K963326BREATHE FITCambridge Assoc.1997-02-12
K962400AIR MAX EXTERNAL NASAL DILATOR STRIPAmerican White Cross, Inc.1996-09-09
K962698ACUTEK'S CLEARPASAGEAcutek Adhesive Specialties, Inc.1996-09-09
K955711BREATHE RIGHT NASAL STRIPCns, Inc.1996-05-30
K954914BREATHE RIGHT NASAL STRIPCns, Inc.1996-02-27
K955233EASY BREATHING NASAL STRIPSCorbett Lair, Inc.1995-12-21
K953042E-Z BREATHERSE-Z Kare Good Health Systems, Inc.1995-12-08
K942025BURGET NASAL STENTBivona Medical Technologies1995-10-27
K953772BREATHE RIGHT NASAL STRIPCns, Inc.1995-10-20
K954252EASY BREATHING NASAL STRIPSCorbett Lair, Inc.1995-10-18
K951644ACUTEK'S CLEARPASSAGEAcutek Adhesive Specialties, Inc.1995-07-03
K921220BREATHE RIGHTCns, Inc.1993-10-07