PS MEDICAL VENTRICULOSTOMY KIT— 510(k) K915546

Clearance details

Applicant

Pudenz-Schulte Medical Research Corp.

Product code

Code HBG

Device class

Class 2

Regulation

21 CFR 882.4300

Advisory panel

Neurology

Date received

1991-12-11

Decision date

1991-12-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Goleta, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K915546.