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510(k) K955482

Device
SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)
Applicant
ADVANTAGE MEDICAL SERVICES, INC.
510(k) number
K955482
Product code
FOG  
Decision
Substantially Equivalent (SESE)
Decision date
1996-01-30
Date received
1995-11-01
Regulation
868.5700
Classification name
Hood, Oxygen, Infant
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
M B FISHER
Address
19380 Hwy. B Edgerton MO US 64444 64444

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FOG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973128OLYMPUS NA-10J-1 ASPIRATION NEEDLEOlympus America, Inc.1997-11-18
K962182BURLEW INFANT HOODPromedic, Inc.1996-07-15
K830781ENDO-GUARDJayco Pharmaceuticals1983-03-31
K792144DISPOSA-HOODUtah Medical Products, Inc.1979-12-05
K791861OXYGEN HOODSAnn Arbor Plastics, Inc.1979-10-04
K790860RT-HOODPlastics Supplies & Products1979-05-29
K780220HOOD, INFANT OXYGENShiley, Inc.1978-04-10
K770754DUODENOSCOPE, MOLEL TX-6American Cystocope Makers, Inc.1977-04-28

Legacy Summary#

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FDA Review#

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