TR-100— 510(k) K161551

Substantially Equivalent

BTL Industries, Inc.

FDA 510(k) clearance K161551 for TR-100, Substantially Equivalent on 2016-09-13. Applicant: BTL Industries, Inc.. Device class: 2.

Clearance details

Applicant: BTL Industries, Inc.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2016-06-03
Decision date: 2016-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Framingham, MA, US

Download summary PDF View on FDA.gov ↗

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