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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyamide
510(k) Number K031531
Device Name S&T MICROSURGICAL SUTURE
Applicant
S & T AG
28438 BALLARD DR.
LAKE FOREST,  IL  60045
Applicant Contact BERNHARD TEITZ
Correspondent
S & T AG
28438 BALLARD DR.
LAKE FOREST,  IL  60045
Correspondent Contact BERNHARD TEITZ
Regulation Number878.5020
Classification Product Code
GAR  
Date Received05/15/2003
Decision Date 09/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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