510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K840362Substantially Equivalent

Comfeel Paste

MEDLINE INDUSTRIES, LP - Northfield, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840362 is the FDA 510(k) clearance record for COMFEEL PASTE, cleared for Coloplast A/S on . FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K840362.

Clearance record

Decision date
Received
(286 days to decision)
Review panel
Unknown
Applicant
Coloplast A/S 200 W. 7th. St., Fort Worth TX
Third party review
No