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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, Steel, Monofilament And Multifilament, Sterile
510(k) Number K933686
Device Name LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE
Applicant
Look, Inc.
2020 Lonnie Abbott Ind. Blvd.
Ada,  OK  74820
Applicant Contact MIKE BOLLINGER
Correspondent
Look, Inc.
2020 Lonnie Abbott Ind. Blvd.
Ada,  OK  74820
Correspondent Contact MIKE BOLLINGER
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received07/29/1993
Decision Date 12/23/1993
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
Predetermined Change
Control Plan Authorized		 No
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