FDA.report

510(k) K970492

Device
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
Applicant
ACKRAD LABORATORIES
510(k) number
K970492
Product code
LKF  
Decision
Substantially Equivalent (SESE)
Decision date
1997-04-09
Date received
1997-02-10
Regulation
884.4530
Classification name
Cannula, Manipulator/injector, Uterine
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
BERNARD ACKERMAN, PH.D.
Address
70 Jackson Dr. Cranford NJ US 07016 07016

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
20888937016394Tampa Catheter for HysterosonographyCoopersurgical, Inc.2017-10-04

Legacy Summary

summary

FDA Review

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