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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 K993970
Device Name MICRINS MICROSURGICAL SUTURE
Applicant
Micrins Surgical, Inc.
28438 Ballard Dr.
Lake Forest,  IL  60045
Applicant Contact BERNHARD TEITZ
Correspondent
Micrins Surgical, Inc.
28438 Ballard Dr.
Lake Forest,  IL  60045
Correspondent Contact BERNHARD TEITZ
Regulation Number878.5020
Classification Product Code
GAR  
Date Received11/23/1999
Decision Date 03/30/2000
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
Predetermined Change
Control Plan Authorized		 No
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