510(k) K864117

SUPPORT ARM by Leonard Medical, Inc.

K864117 is an FDA 510(k) premarket notification submitted by Leonard Medical, Inc. for the device "SUPPORT ARM". The FDA issued a decision of Substantially Equivalent on November 3, 1986. Leonard Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1986
Date Received
October 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No