FDA.report

510(k) K990350

Device
WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
Applicant
COOPERSURGICAL, INC.
510(k) number
K990350
Product code
MQF  
Decision
Substantially Equivalent (SESE)
Decision date
1999-07-26
Date received
1999-02-05
Regulation
884.6110
Classification name
Catheter, Assisted Reproduction
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
DEBRA A PEKAR
Address
15 Forest Pkwy. Shelton CT US 06484 06484

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
30888937021227Wallace Embryo Replacement CatheterCoopersurgical, Inc.2019-12-04
30888937021210Wallace Embryo Replacement CatheterCoopersurgical, Inc.2019-12-04
30888937021203Wallace Embryo Replacement CatheterCoopersurgical, Inc.2019-12-04
30888937021197Wallace Embryo Replacement CatheterCoopersurgical, Inc.2019-12-04

Legacy Summary

summary

FDA Review

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