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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 K091964
Device Name CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
Applicant
Procter & Gamble Co.
8700 Mason-Montgomery Rd.
Mason,  OH  45040
Applicant Contact VICTORIA P SCHOFIELD
Correspondent
Procter & Gamble Co.
8700 Mason-Montgomery Rd.
Mason,  OH  45040
Correspondent Contact VICTORIA P SCHOFIELD
Regulation Number872.6390
Classification Product Code
JES  
Date Received07/01/2009
Decision Date 09/24/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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