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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 K913030
Device Name MAX-I-PROBE IRRIGATION SYSTEM
Applicant
Smith & Nephew, Inc.
9400 King St.
Franklin Park,  IL  60131
Applicant Contact JOHN NAYLER
Correspondent
Smith & Nephew, Inc.
9400 King St.
Franklin Park,  IL  60131
Correspondent Contact JOHN NAYLER
Regulation Number872.6510
Classification Product Code
EFS  
Date Received07/09/1991
Decision Date 09/30/1991
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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