510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864509Substantially Equivalent

Spark-Kit(tm)

Lyphomed, Inc., Melrose Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864509 is the FDA 510(k) clearance record for SPARK-KIT(TM), cleared for Lyphomed, Inc. on . FDA records list 8 510(k) clearances for Lyphomed, Inc., from to . As of , FDA records show no recalls naming K864509.

Clearance record

Decision date
Received
(96 days to decision)
Review panel
Unknown
Applicant
Lyphomed, Inc. 2045 N. Cornell Ave., Melrose Park IL
Third party review
No