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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, Synthetic, Polyglycolic Acid
510(k) Number K060801
Device Name DEKNA-LOK MODEL BP1000V2L
Applicant
Teleflex Medical
2917 Weck Dr.
Durham,  NC  27709
Applicant Contact KIMBERLY EDGERTON
Correspondent
Teleflex Medical
2917 Weck Dr.
Durham,  NC  27709
Correspondent Contact KIMBERLY EDGERTON
Regulation Number878.4493
Classification Product Code
GAM  
Date Received03/24/2006
Decision Date 05/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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