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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, Polypropylene
510(k) Number K020265
Device Name SERRALENE, MODEL CATALOG NO 1S
Applicant
Serral, S.A. DE C.V.
5251-18 John Tyler Hwy.,
Suite 167
Williamsburg,  VA  23185
Applicant Contact SCOTT HENDERSON
Correspondent
Serral, S.A. DE C.V.
5251-18 John Tyler Hwy.,
Suite 167
Williamsburg,  VA  23185
Correspondent Contact SCOTT HENDERSON
Regulation Number878.5010
Classification Product Code
GAW  
Date Received01/25/2002
Decision Date 03/08/2002
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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