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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K950773
Device Name PROPHYLAXIS PACK
Applicant
Transidyne General Corp.
400 Herald Journal Park
Spartanburg,  SC  29303
Applicant Contact STEVEN W BUTLER
Correspondent
Transidyne General Corp.
400 Herald Journal Park
Spartanburg,  SC  29303
Correspondent Contact STEVEN W BUTLER
Regulation Number872.4200
Classification Product Code
EGS  
Date Received02/21/1995
Decision Date 03/31/1995
Decision Substantially Equivalent - Kit (SESK)
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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