510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820827Substantially Equivalent

P105

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

K820827 is the FDA 510(k) clearance record for P105, cleared for Eurotan Intl. on . FDA records list 4 510(k) clearances for Eurotan Intl., from to . As of , FDA records show no recalls naming K820827.

Clearance record

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