BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.

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 Becker External Drainage/monitor Sys Lumbar Cath..

Pre-market Notification Details

• Device ID: K862303
• 510k Number: K862303
• Device Name: BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
• 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: 1986-06-17
• Decision Date: 1986-08-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000031275	K862303	000
00763000572822	K862303	000
00613994806611	K862303	000
00613994806628	K862303	000
00643169466586	K862303	000
00643169483316	K862303	000
00643169507517	K862303	000
00673978228938	K862303	000
00673978237183	K862303	000
00673978239651	K862303	000
00673978245140	K862303	000
00763000027278	K862303	000
00763000027285	K862303	000
00763000028114	K862303	000
00763000029449	K862303	000
00763000031244	K862303	000
00763000529284	K862303	000