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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K771941Substantially Equivalent

Quantrols Im

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

K771941 is the FDA 510(k) clearance record for QUANTROLS IM, cleared for Organon, Inc. on . FDA records list 42 510(k) clearances for Organon, Inc., from to . As of , FDA records show no recalls naming K771941.

Clearance record

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