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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 K903624
Device Name PLAIN AND CHROMIC GUT 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 Number878.4830
Classification Product Code
GAL  
Date Received08/08/1990
Decision Date 09/18/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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