PS MEDICAL DELTA CSF-FLOW CONTROL VALVE

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 Delta Csf-flow Control Valve.

Pre-market Notification Details

• Device ID: K902783
• 510k Number: K902783
• Device Name: PS MEDICAL DELTA CSF-FLOW CONTROL VALVE
• Classification: Shunt, Central Nervous System And Components
• Applicant: PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118
• Contact: Stephen Laguette
• Correspondent: Stephen Laguette; PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118
• Product Code: JXG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-06-26
• Decision Date: 1990-08-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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