BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM

Shunt, Central Nervous System And Components

MEDTRONIC PS MEDICAL

The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Becker External Drainage And Monitoring System.

Pre-market Notification Details

• Device ID: K984053
• 510k Number: K984053
• Device Name: BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Classification: Shunt, Central Nervous System And Components
• Applicant: MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500
• Contact: Jeffrey Henderson
• Correspondent: Jeffrey Henderson; MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-11-06
• Decision Date: 1999-02-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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