NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC— 510(k) K973789

Name: FDA 510(k) clearance K973789
Creator: U.S. Food and Drug Administration
Published: 1998-05-18

Substantially Equivalent

Norian Corp.

FDA 510(k) clearance K973789 for NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC, Substantially Equivalent on 1998-05-18. Applicant: Norian Corp.. Device class: 2.

Clearance details

Applicant: Norian Corp.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 1997-10-06
Decision date: 1998-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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