510(k) K021811

UNIDRIVE II PLUS DISPOSABLE TUBING SET by Mtp Medical Technical Promotion GmbH — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2002
Date Received
June 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type