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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 K864832
Device Name DENTAL FLOSS
Applicant
Westone Products , Ltd.
C/O Arent/Fox/Kint/Plot/Kahn
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact PETER S REICHERTZ
Correspondent
Westone Products , Ltd.
C/O Arent/Fox/Kint/Plot/Kahn
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact PETER S REICHERTZ
Regulation Number872.6390
Classification Product Code
JES  
Date Received12/09/1986
Decision Date 02/10/1987
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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