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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 K860324
Device Name DENTAL FLOSS CARD
Applicant
Washburn Laboratories
1700 Gervais Ave.
Maplewood,  MN  55109
Applicant Contact THOMAS W DWYER
Correspondent
Washburn Laboratories
1700 Gervais Ave.
Maplewood,  MN  55109
Correspondent Contact THOMAS W DWYER
Regulation Number872.6390
Classification Product Code
JES  
Date Received01/29/1986
Decision Date 03/26/1986
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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