510(k) K973914

SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR by Sense Technology, Inc. — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1998
Date Received
October 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manipulator, Plunger-Like Joint
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type