510(k) K861954

HEXAGONAL WRENCHES by Med-Tool, Inc.

K861954 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "HEXAGONAL WRENCHES". The FDA issued a decision of Substantially Equivalent on June 6, 1986. Med-Tool, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1986
Date Received
May 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No