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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Periodontic, Endodontic, Irrigating
510(k) Number K864307
Device Name MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
Applicant
Smith & Nephew, Inc.
1820 W. Roscoe St.
Chicago,  IL  60657
Applicant Contact JAMES F PRINCE
Correspondent
Smith & Nephew, Inc.
1820 W. Roscoe St.
Chicago,  IL  60657
Correspondent Contact JAMES F PRINCE
Regulation Number872.4565
Classification Product Code
EIC  
Date Received11/03/1986
Decision Date 11/18/1986
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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