REIGEL TUNNELING DEVICE— 510(k) K962761

Clearance details

Applicant

Cook, Inc.

Product code

Code GYK

Device class

Class 1

Regulation

21 CFR 882.4545

Advisory panel

Neurology

Date received

1996-07-16

Decision date

1996-10-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bloomington, IN, US

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