510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832393Substantially Equivalent

Encodyne 4 & Vacufix 4

Elmed, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832393 is the FDA 510(k) clearance record for ENCODYNE 4 & VACUFIX 4, cleared for Elmed, Inc. on . FDA records list 11 510(k) clearances for Elmed, Inc., from to . As of , FDA records show no recalls naming K832393.

Clearance record

Decision date
Received
(118 days to decision)
Review panel
Unknown
Applicant
Elmed, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No