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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 K092533
Device Name FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
Applicant
Beere Precision Medical Instruments, Kmedic, Telef
5307 95th Ave.
Kenosha,  WI  53144
Applicant Contact JOY VOIGT
Correspondent
Beere Precision Medical Instruments, Kmedic, Telef
5307 95th Ave.
Kenosha,  WI  53144
Correspondent Contact JOY VOIGT
Regulation Number878.5000
Classification Product Code
GAT  
Date Received08/19/2009
Decision Date 09/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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