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510(k) K890377

Device
FIXED-SIZE UTERINE DILATOR
Applicant
KINETIC MEDICAL PRODUCTS
510(k) number
K890377
Product code
HDQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-02-13
Date received
1989-01-23
Regulation
884.4530
Classification name
Dilator, Cervical, Fixed Size
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES I LAUGHNER
Address
4934 Peach St. Erie PA US 16509 16509

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HDQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930034CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTONThomasville Medical Assoc.1994-02-24
K896701TEFLON CERVICAL ACCESS SETCook Ob/Gyn1990-09-13
K891029CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALLZinnanti Surgical Instruments, Inc.1989-03-17
K811568CERVICAL DILATORGynemetrics, Inc.1981-07-16
K791277MODEL 6500 EXTRACTION IRRIGATION SYSCavitron Corp.1979-08-22

Legacy Summary#

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FDA Review#

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