SYNPLUG— 510(k) K010840

Substantially Equivalent

Isotis NV

FDA 510(k) clearance K010840 for SYNPLUG, Substantially Equivalent on 2001-04-20. Applicant: Isotis NV. Device class: 2.

Clearance details

Applicant: Isotis NV
Product code: Code LZN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2001-03-21
Decision date: 2001-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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