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510(k) K914387

Device
TRANSCERVICAL INTRAUTERINE KIT
Applicant
TELOS MEDICAL CORP.
510(k) number
K914387
Product code
HGS  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-30
Date received
1991-10-01
Regulation
884.2700
Classification name
Catheter, Intrauterine And Introducer
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TIMOTHY J TALCOTT
Address
2044 W. 11th St. Keene CA US 91786 91786

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HGS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K905812INTRAUTERINE CATHETER SETEpcom Medical Systems, Inc.1991-01-31

Legacy Summary#

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FDA Review#

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