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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 K935440
Device Name JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED
Applicant
Johnson & Johnson Consumer Products, Inc.
Grandview Rd.
Skillman,  NJ  08558
Applicant Contact JAMES A HAVILAND
Correspondent
Johnson & Johnson Consumer Products, Inc.
Grandview Rd.
Skillman,  NJ  08558
Correspondent Contact JAMES A HAVILAND
Regulation Number872.6390
Classification Product Code
JES  
Date Received11/12/1993
Decision Date 02/03/1994
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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