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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Periodontic
510(k) Number K880827
Device Name ACCUTEK PERIODONTAL PROBE
Applicant
Sweet Micro Systems, Inc.
50 Freeway Dr.
Cranston,  RI  02920
Applicant Contact NICHOLAS H KONDON
Correspondent
Sweet Micro Systems, Inc.
50 Freeway Dr.
Cranston,  RI  02920
Correspondent Contact NICHOLAS H KONDON
Regulation Number872.4565
Classification Product Code
EIX  
Date Received03/01/1988
Decision Date 04/12/1988
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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