HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT— 510(k) K943334

Name: FDA 510(k) clearance K943334
Creator: U.S. Food and Drug Administration
Published: 1994-10-05

Substantially Equivalent

Jay H. Geller

FDA 510(k) clearance K943334 for HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT, Substantially Equivalent on 1994-10-05. Applicant: Jay H. Geller. Device class: 1.

Clearance details

Applicant: Jay H. Geller
Product code: Code DZC
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1994-07-12
Decision date: 1994-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

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