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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K823413Substantially Equivalent

Mouth Care Kit W/toothbrush

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

K823413 is the FDA 510(k) clearance record for MOUTH CARE KIT W/TOOTHBRUSH, cleared for Sage Products, Inc. on . FDA records list 31 510(k) clearances for Sage Products, Inc., from to . As of , FDA records show no recalls naming K823413.

Clearance record

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