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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Manual
510(k) Number K955530
Device Name RANIR HI-TECHNOLOGY DENTAL FLOSS
Applicant
Ranir/Dcp Corp.
4701 E. Paris SE
Grand Rapids,  MI  49512
Applicant Contact ANNE ARMSTRONG
Correspondent
Ranir/Dcp Corp.
4701 E. Paris SE
Grand Rapids,  MI  49512
Correspondent Contact ANNE ARMSTRONG
Regulation Number872.6855
Classification Product Code
EFW  
Date Received12/04/1995
Decision Date 12/28/1995
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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