510(k) K840979

SLIP JOINT PLIER by Med-Tool, Inc. — Product Code HTC

K840979 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "SLIP JOINT PLIER". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code HTC (Pliers, 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
April 25, 1984
Date Received
March 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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