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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Oral Irrigation
510(k) Number K863131
Device Name PIK POCKET (IRRIGATING TIP)
Applicant
Teledyne, Inc.
1730 E. Prospect St.
Fort Collins,  CO  80525
Applicant Contact DONALD RUEHMANN
Correspondent
Teledyne, Inc.
1730 E. Prospect St.
Fort Collins,  CO  80525
Correspondent Contact DONALD RUEHMANN
Regulation Number872.6510
Classification Product Code
EFS  
Date Received08/15/1986
Decision Date 08/26/1986
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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