CRANIOCAP— 510(k) K000861

Name: FDA 510(k) clearance K000861
Creator: U.S. Food and Drug Administration
Published: 2000-10-30

Substantially Equivalent

Gillette Children'S Specialty Healthcare

FDA 510(k) clearance K000861 for CRANIOCAP, Substantially Equivalent on 2000-10-30. Applicant: Gillette Children'S Specialty Healthcare. Device class: 2.

Clearance details

Applicant: Gillette Children'S Specialty Healthcare
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2000-03-17
Decision date: 2000-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eagan, MN, US

Download summary PDF View on FDA.gov ↗

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