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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positioner, Tooth, Preformed
510(k) Number K833455
Device Name REMOLDABLE CRANIOMANDIBULAR APPLIANCE
Applicant
JEFFREY H. ATTLIN
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JEFFREY H. ATTLIN
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.5525
Classification Product Code
KMY  
Date Received09/27/1983
Decision Date 01/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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