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510(k) K915158

Device
SUREBREATH DOME, E-Z BREATHER
Applicant
IPAX, INC.
510(k) number
K915158
Product code
GAD  
Decision
Substantially Equivalent (SESE)
Decision date
1992-02-12
Date received
1991-11-14
Regulation
878.4800
Classification name
Retractor
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PHILLIP PENNELL
Address
2109 W. Amherst Ave. Englewood CO US 80110 80110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K152538JRP Wound SpreaderJ.R. Parker, LLC2016-04-13
K151104OTELO LLSpineart2016-01-06
K132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.2013-10-04
K071775DASHEzsurgical2007-08-07
K050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.2005-04-26
K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek2005-02-23
K001339MRI FASTSYSTEM RETRACTOR SYSTEMOmni-Tract Surgical, Div. Minn. Scientific, Inc.2000-05-17
K980588CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000Clarus Medical Systems, Inc.1998-08-18
K963006SCION SAPHENOUS VEIN HARVESTING SYSTEMScion International, Inc.1996-09-20
K943875VILLALTA RETRACTORHct, Inc.1994-11-09
K942002RETRACTORAutomated Medical Products Corp.1994-05-17
K941448RETRACTORTechnovations1994-04-15
K930316LUNG RETRACTORS: DAVIDSON, SEMBThomasville Medical Assoc.1994-02-10
K926585THOROCOSCOPY SELF-RETAINING RETRACTORT. Korossurgical Instruments Corp.1993-08-06
K921017HARGIS SR2 SELF-RETRACTION SYSTEMMedin Corp.1993-07-02

Legacy Summary#

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FDA Review#

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