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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 K844626
Device Name MINI FLOW- DENTAL FLOSS
Applicant
Mini Floss
2320 E. Riviera Dr.
Tempe,  AZ  85282
Applicant Contact WILLIAM J MARKO
Correspondent
Mini Floss
2320 E. Riviera Dr.
Tempe,  AZ  85282
Correspondent Contact WILLIAM J MARKO
Regulation Number872.6390
Classification Product Code
JES  
Date Received11/27/1984
Decision Date 01/09/1985
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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