510(k) K870756

VEIN GRAFT EAR SCISSORS by Treace Medical, Inc. — Product Code JZB

K870756 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "VEIN GRAFT EAR SCISSORS". The FDA issued a decision of Substantially Equivalent on March 3, 1987. The device falls under product code JZB (Scissors, Ear), a Class I device regulated under 21 CFR 874.4420. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1987
Date Received
February 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scissors, Ear
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type