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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Natural
510(k) Number K994002
Device Name PLAIN/CHROMIC CATGUT
Applicant
Trading Consultants and Distributors Intl., Inc.
157 Winddance Dr.
Chicago,  IL  60046
Applicant Contact MAIN M GHAZAL
Correspondent
Trading Consultants and Distributors Intl., Inc.
157 Winddance Dr.
Chicago,  IL  60046
Correspondent Contact MAIN M GHAZAL
Regulation Number878.4830
Classification Product Code
GAL  
Date Received11/24/1999
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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