510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K864117Substantially Equivalent

Support Arm

Leonard Medical, Inc., Huntingdon Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864117 is the FDA 510(k) clearance record for SUPPORT ARM, cleared for Leonard Medical, Inc. on . FDA records list 7 510(k) clearances for Leonard Medical, Inc., from to . As of , FDA records show no recalls naming K864117.

Clearance record

Decision date
Received
(13 days to decision)
Review panel
Unknown
Applicant
Leonard Medical, Inc. 1464 Holcomb Rd., Huntingdon Valley PA
Third party review
No