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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture Removal Kit
510(k) Number K922339
Device Name SUTURE REMOVAL KIT
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 Number878.4800
Classification Product Code
MCZ  
Date Received05/19/1992
Decision Date 12/11/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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