510(k) K051397

BIOBANDS by Biobands Distributors, Inc. — Product Code MVV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2005
Date Received
May 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Acupressure
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type