T-SHAPE 2— 510(k) K231092

Substantially Equivalent

B&M S.R.L. Marketing Nel Benessere

FDA 510(k) clearance K231092 for T-SHAPE 2, Substantially Equivalent on 2023-09-22. Applicant: B&M S.R.L. Marketing Nel Benessere. Device class: 2.

Clearance details

Applicant: B&M S.R.L. Marketing Nel Benessere
Product code: Code NUV
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2023-04-18
Decision date: 2023-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milano, IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.