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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 K936221
Device Name PROBE TIP/PERI PROBE/PERI PROBE COMP.
Applicant
Pd International AB
Sloane,  SE
Applicant Contact ANNETTE MATTSSON
Correspondent
Pd International AB
Sloane,  SE
Correspondent Contact ANNETTE MATTSSON
Regulation Number872.4565
Classification Product Code
EIX  
Date Received12/27/1993
Decision Date 08/01/1994
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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