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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 (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Type Traditional
Reviewed by Third Party No
Combination Product No