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510(k) K852625

Device
OXY-TUBE
Applicant
ASHAI CO. LTD.
510(k) number
K852625
Product code
CAT  
Decision
Substantially Equivalent (SESE)
Decision date
1985-09-18
Date received
1985-06-20
Regulation
868.5340
Classification name
Cannula, Nasal, Oxygen
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KALNIN
Address
620 Harris St. Ultimo, N.Sw 2007 Australia AU

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CAT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCIHudson Respiratory Care, Inc.2001-06-13
K935533NASAL CANNULAPuritas Health Care, Inc.1994-02-03
K9223974 SURE TM NASAL OXYGEN CANNULABoston Pacific Medical, Inc.1993-03-18
K921496SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIEDAlpine Specialties, Inc.1992-08-14
K920573CANNULA NASAL OXYGENB & F Medical Products, Inc.1992-08-11
K913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589Specialty Packaging Producs, Inc.1991-10-18
K912197SKIN SAVER(TM) TUBING HOLDER, MODEL 467Alpine Specialties, Inc.1991-08-20
K911740SALTER LABS NEONATAL NASAL OXYGEN CANNULASalter Labs1991-07-24
K902420CATHETER, NASAL, OXYGENGainor Medical Europe, Ltd.1991-04-17
K896036THE COMFORTABLE CANNULAComfortable Concepts Corp.1989-11-17
K892435KENDALL CURITY OXYGEN NASAL CANNULAThe Kendal Co.1989-06-12
K884149COMFORT STRAPComfort Strap Co.1988-10-21
K863431OXYGEN CANNULA EAR WRAP (STYLE A)Salter Labs1986-09-18
K863432OXYGEN CANNULA EAR WRAP (STYLE B)Salter Labs1986-09-18
K860535UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)Andover Medical, Inc.1986-04-01

Legacy Summary#

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FDA Review#

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