THD BANDY— 510(k) K093497

Substantially Equivalent

Thd Spa

FDA 510(k) clearance K093497 for THD BANDY, Substantially Equivalent on 2010-07-15. Applicant: Thd Spa. Device class: 2.

Clearance details

Applicant: Thd Spa
Product code: Code FHN
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2009-11-12
Decision date: 2010-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imoa, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHN

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K172985 — Ligation Device2018-06-14
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K131282 — NEXUS HEMORRHOID LIGATOR2013-07-11
K091519 — HAEMOBAND MULTI-LIGATOR2009-07-28

More clearances from Thd Spa

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K161785 — THD ANOPRESS2017-03-14
K141657 — THD REVOLUTION2015-02-24

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