STERI-OSS SINUS AUGMENTATION KIT— 510(k) K963897

Name: FDA 510(k) clearance K963897
Creator: U.S. Food and Drug Administration
Published: 1996-11-06

Substantially Equivalent

Steri-Oss, Inc.

FDA 510(k) clearance K963897 for STERI-OSS SINUS AUGMENTATION KIT, Substantially Equivalent on 1996-11-06. Applicant: Steri-Oss, Inc.. Device class: 1.

Clearance details

Applicant: Steri-Oss, Inc.
Product code: Code EMM
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1996-09-27
Decision date: 1996-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

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