CRAIGWELL AID HA300— 510(k) K854124

Name: FDA 510(k) clearance K854124
Creator: U.S. Food and Drug Administration
Published: 1986-03-26

Substantially Equivalent

Craigwell Electronics, Ltd.

FDA 510(k) clearance K854124 for CRAIGWELL AID HA300, Substantially Equivalent on 1986-03-26. Applicant: Craigwell Electronics, Ltd.. Device class: 1.

Clearance details

Applicant: Craigwell Electronics, Ltd.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1985-10-09
Decision date: 1986-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wiltshire Sn2 4bj, GB

Download summary PDF View on FDA.gov ↗

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