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510(k) K935665

Device
INTRAUTERINE SOUND
Applicant
ROCKET OF LONDON, LTD.
510(k) number
K935665
Product code
HHM  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-24
Date received
1993-11-26
Regulation
884.4530
Classification name
Sound, Uterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
L. TODD
Address
Wear Industrial Estate Washington Tyne & Wear GB NE37 1NE NE37 1NE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
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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