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510(k) K802165

Device
SHERWOOD VENTILATORY MUSCLE TRAINER
Applicant
SHERWOOD MEDICAL CO.
510(k) number
K802165
Product code
BYW  
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-26
Date received
1980-09-08
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#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K895274HYPEXGlobal Business, Inc.1990-02-23

Legacy Summary#

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FDA Review#

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