STRAUMANN PREFGEL— 510(k) K063812

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K063812 for STRAUMANN PREFGEL, Substantially Equivalent on 2007-01-12. Applicant: Straumann USA. Device class: Unclassified.

Clearance details

Applicant: Straumann USA
Product code: Code KJJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2006-12-22
Decision date: 2007-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, 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.