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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 K844318
Device Name ORAL IRRIGATION TIP
Applicant
Pro Pulse, Inc.
P.O. Box 460
Fort Collins,  CO  80522
Applicant Contact SOUTHARD
Correspondent
Pro Pulse, Inc.
P.O. Box 460
Fort Collins,  CO  80522
Correspondent Contact SOUTHARD
Regulation Number872.6510
Classification Product Code
EFS  
Date Received11/06/1984
Decision Date 11/23/1984
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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