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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K830031Substantially Equivalent

Acrylic Sheet, Plexiglass Mc

Summit Orthodontic Services, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830031 is the FDA 510(k) clearance record for ACRYLIC SHEET, PLEXIGLASS MC, cleared for Summit Orthodontic Services, Inc. on . FDA records list one 510(k) clearance for Summit Orthodontic Services, Inc. As of , FDA records show no recalls naming K830031.

Clearance record

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