P-S MEDICAL CSF-SIPHON CONTROL DEVICE

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 P-s Medical Csf-siphon Control Device.

Pre-market Notification Details

• Device ID: K862907
• 510k Number: K862907
• Device Name: P-S MEDICAL CSF-SIPHON CONTROL DEVICE
• Classification: Shunt, Central Nervous System And Components
• Applicant: PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118
• Contact: Stephen W Laguette
• Correspondent: Stephen W 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: 1986-07-31
• Decision Date: 1986-12-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994908346	K862907	000
00643169466517	K862907	000
00763000028046	K862907	000