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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 K832222
Device Name PRO PULSE PERIODONTAL IRRIGATOR 7618
Applicant
Vipont Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Vipont Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.6510
Classification Product Code
EFS  
Date Received07/08/1983
Decision Date 08/31/1983
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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