CHEMATIC BICARBONATE DIALYSATE SYSTEM— 510(k) K810605

Substantially Equivalent

Trimedyne, Inc.

FDA 510(k) clearance K810605 for CHEMATIC BICARBONATE DIALYSATE SYSTEM, Substantially Equivalent on 1981-06-16. Applicant: Trimedyne, Inc..

Clearance details

Applicant: Trimedyne, Inc.
Product code: Code FKR
Advisory panel: Gastroenterology, Urology
Date received: 1981-03-06
Decision date: 1981-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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