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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K813603
Device Name LINQUAL-ORAL TRAINING SPLINT
Applicant
Charles F. Samelson, M.D.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Charles F. Samelson, M.D.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received12/28/1981
Decision Date 01/26/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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