510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820899Substantially Equivalent

Mecron Voorhoeve Titanium Sheath

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

K820899 is the FDA 510(k) clearance record for MECRON VOORHOEVE TITANIUM SHEATH, cleared for Serrano Intl. on . FDA records list 6 510(k) clearances for Serrano Intl., from to . As of , FDA records show no recalls naming K820899.

Clearance record

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