FDA.report

510(k) K891045

Device
MIYA HOOK
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
510(k) number
K891045
Product code
KNA  
Decision
Substantially Equivalent (SESE)
Decision date
1989-03-22
Date received
1989-02-28
Regulation
884.4530
Classification name
Instrument, Manual, Specialized Obstetric-gynecologic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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