FDA.reportPublic FDA data

510(k) K891029

Device
CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
510(k) number
K891029
Product code
HDQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-03-17
Date received
1989-02-28
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
ANNA STRAIGHT
Address
21540-B Prairie St. Chatsworth CA US 91311 91311

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
K890377FIXED-SIZE UTERINE DILATORKinetic Medical Products1989-02-13
K811568CERVICAL DILATORGynemetrics, Inc.1981-07-16
K791277MODEL 6500 EXTRACTION IRRIGATION SYSCavitron Corp.1979-08-22

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases