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510(k) K941391

Device
INFLATABLE RETENTION CUFF SPECULUM
Applicant
INNOVATEC MEDICAL CORP.
510(k) number
K941391
Product code
GBT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-20
Date received
1994-03-22
Regulation
876.5980
Classification name
Catheter, Rectal
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROY ABELL
Address
4809 Riverview Way Duluth GA US 30097 30097

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
K924549TRI-MED QUICK-STEP(TM) RECTAL TUBETri-Med Specialties, Inc.1994-02-10
K890466SIGMOID TONOMITORTonometrics, Inc.1989-04-21

Legacy Summary#

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FDA Review#

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