OBTURATION SYSTEM KIT— 510(k) K820639

Substantially Equivalent

U.S. Shizai Corp.

FDA 510(k) clearance K820639 for OBTURATION SYSTEM KIT, Substantially Equivalent on 1982-04-09. Applicant: U.S. Shizai Corp.. Device class: 1.

Clearance details

Applicant: U.S. Shizai Corp.
Product code: Code EKM
Device class: Class 1
Regulation: 21 CFR 872.3850
Advisory panel: Dental
Date received: 1982-03-08
Decision date: 1982-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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