510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843013Substantially Equivalent

H-H Tendeon Implant

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

K843013 is the FDA 510(k) clearance record for H-H TENDEON IMPLANT, cleared for Holter-Hausner Intl. on . FDA records list 42 510(k) clearances for Holter-Hausner Intl., from to . As of , FDA records show no recalls naming K843013.

Clearance record

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