ELITE— 510(k) K812538

Substantially Equivalent

Biotone International, Inc.

FDA 510(k) clearance K812538 for ELITE, Substantially Equivalent on 1981-12-01. Applicant: Biotone International, Inc..

Clearance details

Applicant: Biotone International, Inc.
Product code: Code IPF
Advisory panel: Physical Medicine
Date received: 1981-09-03
Decision date: 1981-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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