510(k) K901531

PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE by Pioneering Technologies, Inc. — Product Code DNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1990
Date Received
March 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Ethosuximide
Device Class
Class II
Regulation Number
862.3380
Review Panel
TX
Submission Type