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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 K902325
Device Name DENTAL CLEANING RINGS
Applicant
H. Bernath & Assoc.
Post Office Box 767481
Roswell,  GA  30076
Applicant Contact HAROLD BERNATH
Correspondent
H. Bernath & Assoc.
Post Office Box 767481
Roswell,  GA  30076
Correspondent Contact HAROLD BERNATH
Regulation Number872.6390
Classification Product Code
JES  
Date Received05/24/1990
Decision Date 11/13/1990
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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