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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K111828
Device Name CLEARSPLINT ES
Applicant
ASTRON DENTAL CORPORATION
815 OAKWOOD RD. UNIT G
LAKE ZURICH,  IL  60047
Applicant Contact DOUGLAS S MULLER
Correspondent
ASTRON DENTAL CORPORATION
815 OAKWOOD RD. UNIT G
LAKE ZURICH,  IL  60047
Correspondent Contact DOUGLAS S MULLER
Classification Product Code
MQC  
Date Received06/28/2011
Decision Date 10/26/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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