510(k) K874356

PIN PUNCH by Med-Tool, Inc. — Product Code LRY

K874356 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "PIN PUNCH". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code LRY (Punch, Surgical), a Class I device regulated under 21 CFR 878.4800. Med-Tool, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1987
Date Received
October 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Punch, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type