POWER DRIVE— 510(k) K012944

Substantially Equivalent

Mediteam AB

FDA 510(k) clearance K012944 for POWER DRIVE, Substantially Equivalent on 2001-11-20. Applicant: Mediteam AB. Device class: 1.

Clearance details

Applicant
Mediteam AB
Product code
Code EKX
Device class
Class 1
Regulation
21 CFR 872.4200
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Savedalen, SE
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