510(k) K011554

LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT by Biomet, Inc. — Product Code MIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2001
Date Received
May 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Vocal Cord Medialization
Device Class
Class II
Regulation Number
874.3620
Review Panel
EN
Submission Type