Csf-ventriculostomy Reservoir 510(k) FDA Premarket Notification K874498 PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

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

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CSF-VENTRICULOSTOMY RESERVOIR

Port & Catheter, Implanted, Subcutaneous, Intraventricular

PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

Pre-market Notification Details

NIH GUDID Devices