510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K771569Substantially Equivalent

Autostreaker

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

K771569 is the FDA 510(k) clearance record for AUTOSTREAKER, cleared for Tomtec on . FDA records list 2 510(k) clearances for Tomtec, from to . As of , FDA records show no recalls naming K771569.

Clearance record

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