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510(k) K870550

Device
TEFLON UTERINE SOUND
Applicant
COOK OB/GYN
510(k) number
K870550
Product code
HHM  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-04
Date received
1987-02-10
Regulation
884.4530
Classification name
Sound, Uterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DEXTER J ELKINS
Address
925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HHM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011840CERVILENZ UTERINE MEASURING SOUNDCervilenz, Inc.2001-08-10
K935665INTRAUTERINE SOUNDRocket of London, Ltd.1994-02-24
K884684ROCKET INTRAUTERINE DEPTH SOUNDA & A Medical, Inc.1988-12-20
K883806ROCKET INTRAUTERINE SOUNDA & A Medical, Inc.1988-10-31
K840380UTERINE SOUNDIntl. Medical Technologies, Inc.1984-04-30
K831224AUGROS HYSTEROMETERAxcan Scientific Corp.1983-10-28
K802315UTERINE SOUNDGynemetrics, Inc.1981-01-12
K781766UTERINE SOUND, BURNETT DISPOSABLEC.R. Bard, Inc.1978-12-07
K760170INTRAUTERINE SOUND, PLASTIC DISPOSABLEG.D. Searle and Co.1976-07-19

Legacy Summary#

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FDA Review#

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