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510(k) K811568

Device
CERVICAL DILATOR
Applicant
GYNEMETRICS, INC.
510(k) number
K811568
Product code
HDQ  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-16
Date received
1981-06-04
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#

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 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
K890377FIXED-SIZE UTERINE DILATORKinetic Medical Products1989-02-13
K791277MODEL 6500 EXTRACTION IRRIGATION SYSCavitron Corp.1979-08-22

Legacy Summary#

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FDA Review#

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