510(k) K082134

CIRCULATOR BOOT by Circulator Boot Corp. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2009
Date Received
July 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type