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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 K882828
Device Name DENTAL FLOSS PICK
Applicant
Bik Pik
1081 Parlane Office Park
Suite 112
Wichita,  KS  67218
Applicant Contact EDWARD SIEMS
Correspondent
Bik Pik
1081 Parlane Office Park
Suite 112
Wichita,  KS  67218
Correspondent Contact EDWARD SIEMS
Regulation Number872.6390
Classification Product Code
JES  
Date Received07/08/1988
Decision Date 08/12/1988
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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