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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, polyethylene
510(k) Number K943949
Device Name POLYVIOLENE SURGICL 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
GAT  
Date Received08/02/1994
Decision Date 11/10/1994
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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