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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 K897053
Device Name L'LL SQUIRT GUM ORAL RINSE DEVICE
Applicant
James R. Powell
480 Roe Ave.
Elmira,  NY  14901
Applicant Contact JAMES R POWELL
Correspondent
James R. Powell
480 Roe Ave.
Elmira,  NY  14901
Correspondent Contact JAMES R POWELL
Regulation Number872.6510
Classification Product Code
EFS  
Date Received12/18/1989
Decision Date 08/06/1990
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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