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510(k) K011125

Device
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
Applicant
HUDSON RESPIRATORY CARE, INC.
510(k) number
K011125
Product code
CAT  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-13
Date received
2001-04-13
Regulation
868.5340
Classification name
Cannula, Nasal, Oxygen
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEANNIE L DENNING
Address
27711 Diaz Rd. P.O. Box 9020 Temecula CA US 92589 92589

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CAT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K863432OXYGEN CANNULA EAR WRAP (STYLE B)Salter Labs1986-09-18
K863431OXYGEN CANNULA EAR WRAP (STYLE A)Salter Labs1986-09-18
K860535UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)Andover Medical, Inc.1986-04-01
K860872NASAL CANNULA W/2M & 5M TUBINGDhd Medical Products Div. Diemolding Corp.1986-03-19

Legacy Summary#

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FDA Review#

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