OVUM PICK-UP ASPIRATION NEEDLES

Needle, Assisted Reproduction

COOK OB/GYN

The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Ovum Pick-up Aspiration Needles.

Pre-market Notification Details

• Device ID: K983593
• 510k Number: K983593
• Device Name: OVUM PICK-UP ASPIRATION NEEDLES
• Classification: Needle, Assisted Reproduction
• Applicant: COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460
• Contact: Debbie Schmitt
• Correspondent: Debbie Schmitt; COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460
• Product Code: MQE
• CFR Regulation Number: 884.6100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-10-13
• Decision Date: 1999-01-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00827002443587	K983593	000
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