LT-300 HD— 510(k) K160380

Substantially Equivalent

Lutech Industries, Inc.

FDA 510(k) clearance K160380 for LT-300 HD, Substantially Equivalent on 2016-05-13. Applicant: Lutech Industries, Inc..

Clearance details

Applicant: Lutech Industries, Inc.
Product code: Code HEX
Advisory panel: Obstetrics/Gynecology
Date received: 2016-02-10
Decision date: 2016-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, US

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