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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 K944886
Device Name COLGATE PRECISION MINT WZXED DENTAL FLOSS
Applicant
Colgate-Palmolive Co.
P.O. Box 1343
909 River Rd.
Piscataway,  NJ  08855 -1343
Applicant Contact PAUL J OKARMA
Correspondent
Colgate-Palmolive Co.
P.O. Box 1343
909 River Rd.
Piscataway,  NJ  08855 -1343
Correspondent Contact PAUL J OKARMA
Regulation Number872.6390
Classification Product Code
JES  
Date Received10/03/1994
Decision Date 04/27/1995
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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