FDA.report

510(k) K990349

Device
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
Applicant
COOPERSURGICAL, INC.
510(k) number
K990349
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 PARKER
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
30888937021326Wallace Rigid Stylet for 23 cm CatheterCoopersurgical, Inc.2019-12-04
30888937021319Wallace Rigid Stylet for 18cm CatheterCoopersurgical, Inc.2019-12-04
30888937021302Wallace SurePro Ultra Embryo Replacement Catheter w/ StyletCoopersurgical, Inc.2019-12-04
30888937021296Wallace SurePro Ultra Embryo Replacement Catheter w/ Obturator Coopersurgical, Inc.2019-12-04
30888937021289Wallace SurePro Ultra Embryo Replacement CatheterCoopersurgical, Inc.2019-12-04

Legacy Summary

summary

FDA Review

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