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510(k) K891037

Device
WEIGHTED SPECULA-STEINER,HENROTIN,BERLAND,GARRIGUE
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
510(k) number
K891037
Product code
HFD  
Decision
Substantially Equivalent (SESE)
Decision date
1989-03-17
Date received
1989-02-28
Regulation
884.1185
Classification name
Washer, Endometrial
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANNA STRAIGHT
Address
21540-B Prairie St. Chatsworth CA US 91311 91311

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890376VAGINAL SPECULUMKinetic Medical Products1989-02-27
K810558SKIN SCRUB TRAYAssociated Medical Products Co.1981-03-17

Legacy Summary#

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FDA Review#

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