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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 K905188
Device Name PERIO PIK
Original Applicant
1730 east prospect rd.
fort collins,  CO  80525 -1310
Original Contact donald ruehmann
Regulation Number872.6510
Classification Product Code
Date Received11/19/1990
Decision Date 02/15/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No