CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL— 510(k) K873689

Name: FDA 510(k) clearance K873689
Creator: U.S. Food and Drug Administration
Published: 1987-10-26

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K873689 for CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL, Substantially Equivalent on 1987-10-26. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 1987-09-11
Decision date: 1987-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

Download summary PDF View on FDA.gov ↗

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