510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K811117Substantially Equivalent

Eye Care Tray

American Pharmaseal Div. Ahsc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811117 is the FDA 510(k) clearance record for EYE CARE TRAY, cleared for American Pharmaseal Div. Ahsc on . FDA records list 64 510(k) clearances for American Pharmaseal Div. Ahsc, from to . As of , FDA records show no recalls naming K811117.

Clearance record

Decision date
Received
(83 days to decision)
Review panel
Unknown
Applicant
American Pharmaseal Div. Ahsc 803 N. Front St. Suite 3, Mchenry IL
Third party review
No