BIOCELLECT— 510(k) K010775

Substantially Equivalent

Imtec Corp.

FDA 510(k) clearance K010775 for BIOCELLECT, Substantially Equivalent on 2001-06-12. Applicant: Imtec Corp.. Device class: 2.

Clearance details

Applicant: Imtec Corp.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2001-03-14
Decision date: 2001-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ardmore, OK, 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.