TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*— 510(k) K864835

Name: FDA 510(k) clearance K864835
Creator: U.S. Food and Drug Administration
Published: 1987-02-11

Substantially Equivalent

Eisai U.S.A., Inc.

FDA 510(k) clearance K864835 for TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*, Substantially Equivalent on 1987-02-11. Applicant: Eisai U.S.A., Inc..

Clearance details

Applicant: Eisai U.S.A., Inc.
Product code: Code FCD
Advisory panel: Gastroenterology, Urology
Date received: 1986-12-09
Decision date: 1987-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

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