510(k) K873715

BONE PIN CUTTER 18 by Military Engineering, Inc. — Product Code HXZ

K873715 is an FDA 510(k) premarket notification submitted by Military Engineering, Inc. for the device "BONE PIN CUTTER 18". The FDA issued a decision of Substantially Equivalent on October 28, 1987. The device falls under product code HXZ (Cutter, Wire), a Class I device regulated under 21 CFR 888.4540. Military Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1987
Date Received
September 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cutter, Wire
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type