510(k) K870349

BIODYNAMICS FEMORAL CANAL BRUSH #1201 by Biodynamic Technologies, Inc. — Product Code HTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1987
Date Received
January 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rasp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type