510(k) K940669

J.B.S. B.A.C. PIN by J.B.S., S.A. — Product Code HTY

K940669 is an FDA 510(k) premarket notification submitted by J.B.S., S.A. for the device "J.B.S. B.A.C. PIN". The FDA issued a decision of Substantially Equivalent on Nov 14, 1994. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. J.B.S., S.A. has 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 14, 1994
Date Received
Feb 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K940669. Report a data issue: hello@regdatalab.com.