510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780817Substantially Equivalent

Globin-Terge

Simmler & Son, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780817 is the FDA 510(k) clearance record for GLOBIN-TERGE, cleared for Simmler & Son, Inc. on . FDA records list 14 510(k) clearances for Simmler & Son, Inc., from to . As of , FDA records show no recalls naming K780817.

Clearance record

Decision date
Received
(70 days to decision)
Review panel
Unknown
Applicant
Simmler & Son, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No