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510(k) K890466

Device
SIGMOID TONOMITOR
Applicant
TONOMETRICS, INC.
510(k) number
K890466
Product code
GBT  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-21
Date received
1989-01-31
Regulation
876.5980
Classification name
Catheter, Rectal
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
L MACKEEN,PHD
Address
4903 Sangamore Rd. Bethesda MD US 20816 20816

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GBT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K941391INFLATABLE RETENTION CUFF SPECULUMInnovatec Medical Corp.1994-10-20
K924549TRI-MED QUICK-STEP(TM) RECTAL TUBETri-Med Specialties, Inc.1994-02-10

Legacy Summary#

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FDA Review#

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