510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812052Substantially Equivalent

Myocath Catolog No. Mck-a

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

K812052 is the FDA 510(k) clearance record for MYOCATH CATOLOG NO. MCK-A, cleared for Sorensen Research on . FDA records list 69 510(k) clearances for Sorensen Research, from to . As of , FDA records show no recalls naming K812052.

Clearance record

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