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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Periodontic
510(k) Number K871504
Device Name DISPOSABLE PERIODONTAL PROBE
Applicant
Periodontal Health Brush, Inc.
Box 101, R3
Hwy. 53
Osseo,  WI  54758
Applicant Contact JEFFREY NOVAK
Correspondent
Periodontal Health Brush, Inc.
Box 101, R3
Hwy. 53
Osseo,  WI  54758
Correspondent Contact JEFFREY NOVAK
Regulation Number872.4565
Classification Product Code
EIX  
Date Received04/17/1987
Decision Date 05/06/1987
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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