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510(k) K951644

Device
ACUTEK'S CLEARPASSAGE
Applicant
ACUTEK ADHESIVE SPECIALTIES, INC.
510(k) number
K951644
Product code
LWF  
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-03
Date received
1995-04-10
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
GREG HOLLAND
Address
540 N. Oak St. Inglewood CA US 90302 90302

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
K982929MAXAIR NASAL DILATOR SYSTEMHnl Technologies1998-09-09
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
K921220BREATHE RIGHTCns, Inc.1993-10-07

Legacy Summary#

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FDA Review#

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