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510(k) K924944

Device
INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA
Applicant
WESTMED INTL.
510(k) number
K924944
Product code
EMX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-02
Date received
1992-09-30
Regulation
874.4100
Classification name
Balloon, Epistaxis
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
LYNN HAYSE
Address
3351 E. Hemisphere Loop Tucson AZ US 85706 85706

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EMX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintHemostasis, LLC2022-11-14
K041446NASALCEASELes Laboratorires Brothier, S.A.2004-07-01
K000108RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100Bhk Holding2000-05-23
K993362HYLASINEBiomatrix, Inc.2000-03-13
K983276HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLC1999-09-14
K982731MEROGEL NASAL DRESSING AND SINUS STENTXomed, Inc.1999-02-02
K984069ENTAXIS NASAL PACKINGLes Laboratorires Brothier, S.A.1999-01-25
K981966NOSEBLEED NOSECLIPMichael M. Knott, M.D.1998-08-14
K973656DISPOSABLE SILICONE EPISTAXIS CATHETERSpecialty Surgical Products, Inc.1997-11-18
K973085ULTRACELL PACKING WITH SLEEVEUltracell Medical Technologies, Inc.1997-11-18
K972922VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703KInterview Medical Technology Corp.1997-10-08
K972459RHINOCELL NASAL PACKINGSBoston Medical Products, Inc.1997-08-04
K972078POST-STOP EPISTAXIS CATHETERBoston Medical Products, Inc.1997-07-10
K972077EPI-STOP EPISTAXIS CATHETERBoston Medical Products, Inc.1997-06-26
K972076EPI-MAX EPISTAXIS CATHETERBoston Medical Products, Inc.1997-06-26

Legacy Summary#

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FDA Review#

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