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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 K901955
Device Name PERIOGARD(R) PERIOPEN
Applicant
Colgate-Palmolive Co.
909 River Rd.
Piscataway,  NJ  08855
Applicant Contact CRAIG E HAMMES
Correspondent
Colgate-Palmolive Co.
909 River Rd.
Piscataway,  NJ  08855
Correspondent Contact CRAIG E HAMMES
Regulation Number872.6510
Classification Product Code
EFS  
Date Received05/01/1990
Decision Date 04/15/1991
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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