510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K840403Substantially Equivalent

Vena * Bridge

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

K840403 is the FDA 510(k) clearance record for VENA * BRIDGE, cleared for Neward Enterprises, Inc. on . FDA records list 8 510(k) clearances for Neward Enterprises, Inc., from to . As of , FDA records show no recalls naming K840403.

Clearance record

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