OPUS I OPTION - FIBER OPTIC L SYSTEM— 510(k) K761331

Name: FDA 510(k) clearance K761331
Creator: U.S. Food and Drug Administration
Published: 1977-01-03

Substantially Equivalent

Syntex Corp.

FDA 510(k) clearance K761331 for OPUS I OPTION - FIBER OPTIC L SYSTEM, Substantially Equivalent on 1977-01-03. Applicant: Syntex Corp.. Device class: 1.

Clearance details

Applicant: Syntex Corp.
Product code: Code EAY
Device class: Class 1
Regulation: 21 CFR 872.4620
Advisory panel: Dental
Date received: 1976-12-27
Decision date: 1977-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K831976 — POWER OPTIC1983-08-12

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K780997 — AMALGAM ALLOY1978-07-27
K780769 — S-100 CT SCANNER1978-06-02
K780483 — FIBER OPTIC HANDPIECE1978-04-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.