CSF-VENTRICULOSTOMY RESERVOIR

Port & Catheter, Implanted, Subcutaneous, Intraventricular

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 Csf-ventriculostomy Reservoir.

Pre-market Notification Details

• Device ID: K874498
• 510k Number: K874498
• Device Name: CSF-VENTRICULOSTOMY RESERVOIR
• Classification: Port & Catheter, Implanted, Subcutaneous, Intraventricular
• Applicant: PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118
• Contact: W Laguette
• Correspondent: W Laguette; PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118
• Product Code: LKG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-11-02
• Decision Date: 1988-02-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169472327	K874498	000
00763000030483	K874498	000
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