510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K813603Substantially Equivalent

Linqual-Oral Training Splint

Charles F. Samelson, M.D., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813603 is the FDA 510(k) clearance record for LINQUAL-ORAL TRAINING SPLINT, cleared for Charles F. Samelson, M.D. on . FDA records list one 510(k) clearance for Charles F. Samelson, M.D. As of , FDA records show no recalls naming K813603.

Clearance record

Decision date
Received
(29 days to decision)
Review panel
Unknown
Applicant
Charles F. Samelson, M.D. 4221 Richmond Rd., NW, Walker MI
Third party review
No