510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863964Substantially Equivalent

Limb-Guard

Sparco, Inc., Castro Valley CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863964 is the FDA 510(k) clearance record for LIMB-GUARD, cleared for Sparco, Inc. on . FDA records list 6 510(k) clearances for Sparco, Inc., from to . As of , FDA records show no recalls naming K863964.

Clearance record

Decision date
Received
(14 days to decision)
Review panel
Unknown
Applicant
Sparco, Inc. P.O. Box 20369, Castro Valley CA
Third party review
No