IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B

Catheter, Assisted Reproduction

GYNETICS MEDICAL PRODUCTS NV

The following data is part of a premarket notification filed by Gynetics Medical Products Nv with the FDA for Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 A, B.

Pre-market Notification Details

• Device ID: K013501
• 510k Number: K013501
• Device Name: IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
• Classification: Catheter, Assisted Reproduction
• Applicant: GYNETICS MEDICAL PRODUCTS NV 3722 AVE. SAUSALITO Irvine, CA 92606
• Contact: Grace Holland
• Correspondent: Grace Holland; GYNETICS MEDICAL PRODUCTS NV 3722 AVE. SAUSALITO Irvine, CA 92606
• Product Code: MQF
• CFR Regulation Number: 884.6110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-10-22
• Decision Date: 2001-11-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15425017502088	K013501	000
25425017502061	K013501	000
25425017502054	K013501	000
25425017502047	K013501	000
25425017502030	K013501	000
25425017502023	K013501	000
25425017502016	K013501	000
25425017502009	K013501	000