510(k) K062610

CARE-E-VAC 3 by Ohio Medical Corporation — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2006
Date Received
September 5, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type