PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT

Shunt, Central Nervous System And Components

PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ps Medical Bioglide Csf-flow Control Shunt Kit.

Pre-market Notification Details

• Device ID: K951258
• 510k Number: K951258
• Device Name: PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
• Classification: Shunt, Central Nervous System And Components
• Applicant: PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 125 CREMONA DR. Goleta, CA 93117
• Contact: Tom Holdych
• Correspondent: Tom Holdych; PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 125 CREMONA DR. Goleta, CA 93117
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-03-21
• Decision Date: 1995-09-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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