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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 K931380
Device Name WATER PIK PLUS PLAQUE CONTROL SYSTEM
Applicant
Teledyne Water Pik
1730 E. Prospect Rd.
Fort Collins,  CO  80525
Applicant Contact CODY RILEY
Correspondent
Teledyne Water Pik
1730 E. Prospect Rd.
Fort Collins,  CO  80525
Correspondent Contact CODY RILEY
Regulation Number872.6510
Classification Product Code
EFS  
Date Received03/18/1993
Decision Date 09/20/1993
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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