510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811519Substantially Equivalent

K-Flex

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

K811519 is the FDA 510(k) clearance record for K-FLEX, cleared for Sybron Corp. on . FDA records list 37 510(k) clearances for Sybron Corp., from to . As of , FDA records show no recalls naming K811519.

Clearance record

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