510(k) K870329

ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 by Biodynamic Technologies, Inc. — Product Code HTR

K870329 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202". The FDA issued a decision of Substantially Equivalent on February 13, 1987. The device falls under product code HTR (Rasp), a Class I device regulated under 21 CFR 878.4800. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.

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