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510(k) K895274

Device
HYPEX
Applicant
GLOBAL BUSINESS, INC.
510(k) number
K895274
Product code
BYW  
Decision
Substantially Equivalent (SESE)
Decision date
1990-02-23
Date received
1989-08-23
Regulation
868.5675
Classification name
Device, Rebreathing
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LENKEY III
Address
2121 Castlebridge Rd. Midlothian VA US 23113 23113

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K802165SHERWOOD VENTILATORY MUSCLE TRAINERSherwood Medical Co.1980-09-26

Legacy Summary#

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FDA Review#

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