510(k) K844600

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

K844600 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "SLIP JOINT PLIERS". The FDA issued a decision of Substantially Equivalent on December 14, 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
December 14, 1984
Date Received
November 27, 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