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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, polyester
510(k) Number K904054
Device Name POLYVIOLENE(TM) SUTURE
Applicant
LOOK, INC.
2020 LONNIE ABBOTT IND. BLVD.
ADA,  OK  74820
Applicant Contact GARY AINSWORTH
Correspondent
LOOK, INC.
2020 LONNIE ABBOTT IND. BLVD.
ADA,  OK  74820
Correspondent Contact GARY AINSWORTH
Regulation Number878.5000
Classification Product Code
GAS  
Date Received07/31/1990
Decision Date 10/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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