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510(k) K960401

Device
ULTIMATE SEAL
Applicant
HANS RUDOLPH, INC.
510(k) number
K960401
Product code
KGB  
Decision
Substantially Equivalent (SESE)
Decision date
1996-06-20
Date received
1996-01-29
Regulation
868.5570
Classification name
Mask, Oxygen, Non-rebreathing
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KEVIN RUDOLPH
Address
7200 Wyandotte Kansas City MO US 64114 64114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KGB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970688POCKET RESCUECheen Houng Ent. Co. , Ltd.1997-09-26
K941336COMBO MASKGam Industries, Inc.1994-09-09
K935917CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems Preanalytic1994-02-04
K932347COMPACT MASKVital Signs, Inc.1994-01-10
K933583NONREBREATHING VALVEHans Rudolph, Inc.1994-01-03
K933048LAERDAL(TM) POCKET MASK, MODIFICATIONLaerdal Medical Corp.1993-12-02
K930336PROFAST(R)-DENTURE ADHESIVE CREAMFittydent-Altwirth & Schmitt GmbH1993-08-24
K913164NON REBREATHING MASKSpecialty Packaging Producs, Inc.1992-01-15
K883766MOUTH-TO-MASK VENTILATORY ADJUNCTMedic One1988-10-21
K790161OXYGEN MASK W/RESERVOIR BAGAirlife, Inc.1979-04-20
K790162OXYGEN MASK, CONCENTRATION AEROSOL MASKAirlife, Inc.1979-04-20
K781414MASK, OXYGEN, NONBREATHINGVitalab Products Corp.1978-09-07

Legacy Summary#

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FDA Review#

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