P-S MEDICAL CSF ACCESS DEV 15MM/25MM

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 P-s Medical Csf Access Dev 15mm/25mm.

Pre-market Notification Details

• Device ID: K833822
• 510k Number: K833822
• Device Name: P-S MEDICAL CSF ACCESS DEV 15MM/25MM
• Classification: Port & Catheter, Implanted, Subcutaneous, Intraventricular
• Applicant: PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: LKG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-11-02
• Decision Date: 1984-05-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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