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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 K980953
Device Name ACCU-BITE HOME KIT DISCLUDER
Applicant
Jerome M. Simon
1500 Summer St.
Stamford,  CT  06905
Applicant Contact JEROME M SIMON
Correspondent
Jerome M. Simon
1500 Summer St.
Stamford,  CT  06905
Correspondent Contact JEROME M SIMON
Classification Product Code
MQC  
Date Received03/13/1998
Decision Date 10/07/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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