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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 K944848
Device Name THE VIVACARE T.P.S. PROBE
Applicant
Rms Div.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact LYOD V ZIEMENDORF
Correspondent
Rms Div.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact LYOD V ZIEMENDORF
Regulation Number872.4565
Classification Product Code
EIX  
Date Received09/30/1994
Decision Date 12/14/1994
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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