WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316

Catheter, Assisted Reproduction

COOPERSURGICAL, INC.

The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Wallace Catheters-18cm, Model 1816; 23cm, Model 1816n; 23cm, Model 2316.

Pre-market Notification Details

• Device ID: K990350
• 510k Number: K990350
• Device Name: WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
• Classification: Catheter, Assisted Reproduction
• Applicant: COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484
• Contact: Debra A Pekar
• Correspondent: Debra A Pekar; COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484
• Product Code: MQF
• CFR Regulation Number: 884.6110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-02-05
• Decision Date: 1999-07-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30888937021227	K990350	000
30888937021210	K990350	000
30888937021203	K990350	000
30888937021197	K990350	000