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510(k) K802315

Device
UTERINE SOUND
Applicant
GYNEMETRICS, INC.
510(k) number
K802315
Product code
HHM  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-12
Date received
1980-09-23
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#

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 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
K870550TEFLON UTERINE SOUNDCook Ob/Gyn1987-03-04
K840380UTERINE SOUNDIntl. Medical Technologies, Inc.1984-04-30
K831224AUGROS HYSTEROMETERAxcan Scientific Corp.1983-10-28
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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