PS MEDICAL CRANIAL HAND DRILL— 510(k) K904283

Name: FDA 510(k) clearance K904283
Creator: U.S. Food and Drug Administration
Published: 1990-10-03

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K904283 for PS MEDICAL CRANIAL HAND DRILL, Substantially Equivalent on 1990-10-03. Applicant: Pudenz-Schulte Medical Research Corp.. Device class: 2.

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: 1990-09-17
Decision date: 1990-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

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