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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 K895259
Device Name PIK POCKET(R), MODEL PP-3
Applicant
Teledyne Water Pik
1730 E. Prospect Rd.
Fort Collins,  CO  80525
Applicant Contact DONALD W RUEHMANN
Correspondent
Teledyne Water Pik
1730 E. Prospect Rd.
Fort Collins,  CO  80525
Correspondent Contact DONALD W RUEHMANN
Regulation Number872.6510
Classification Product Code
EFS  
Date Received06/02/1989
Decision Date 11/01/1989
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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