OPTIUM DBM GEL AND PUTTY— 510(k) K053098

Substantially Equivalent

Lifenet

FDA 510(k) clearance K053098 for OPTIUM DBM GEL AND PUTTY, Substantially Equivalent on 2005-11-28. Applicant: Lifenet. Device class: 2.

Clearance details

Applicant: Lifenet
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2005-11-03
Decision date: 2005-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virginia Beach, VA, 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.