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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K853463Substantially Equivalent

Lx Embedding Center

Innovative Medical Systems, Inc., Ivyland PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853463 is the FDA 510(k) clearance record for LX EMBEDDING CENTER, cleared for Innovative Medical Systems, Inc. on . FDA records list 22 510(k) clearances for Innovative Medical Systems, Inc., from to . As of , FDA records show no recalls naming K853463.

Clearance record

Decision date
Received
(9 days to decision)
Review panel
Unknown
Applicant
Innovative Medical Systems, Inc. 55 Steamwhistle Dr., Ivyland PA
Third party review
No