VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4— 510(k) K911613

Name: FDA 510(k) clearance K911613
Creator: U.S. Food and Drug Administration
Published: 1991-06-28

Substantially Equivalent

Exmoor Plastics , Ltd.

FDA 510(k) clearance K911613 for VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4, Substantially Equivalent on 1991-06-28. Applicant: Exmoor Plastics , Ltd.. Device class: 2.

Clearance details

Applicant: Exmoor Plastics , Ltd.
Product code: Code LCR
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1991-04-03
Decision date: 1991-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taunton, GB

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