AMALGAMATOR MODEL SDC--— 510(k) K791410

Name: FDA 510(k) clearance K791410
Creator: U.S. Food and Drug Administration
Published: 1979-09-19

Substantially Equivalent

Sierra Laboratories, Inc.

FDA 510(k) clearance K791410 for AMALGAMATOR MODEL SDC--, Substantially Equivalent on 1979-09-19. Applicant: Sierra Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Sierra Laboratories, Inc.
Product code: Code EFD
Device class: Class 1
Regulation: 21 CFR 872.3100
Advisory panel: Dental
Date received: 1979-07-12
Decision date: 1979-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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