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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Floss, Dental
510(k) Number K853767
Device Name FLOSPIK
Applicant
Medelco , Ltd.
1670 S. Ave.
Stratford,  CT  06497
Applicant Contact WILLIAM J SEIDEL
Correspondent
Medelco , Ltd.
1670 S. Ave.
Stratford,  CT  06497
Correspondent Contact WILLIAM J SEIDEL
Regulation Number872.6390
Classification Product Code
JES  
Date Received09/09/1985
Decision Date 12/02/1985
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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