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510(k) Data Aggregation
K Number
K092533Device Name
FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES
Manufacturer
BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF
Date Cleared
2009-09-15
(27 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Force Fiber® Blue Ultra High Molecular Weight Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
Device Description
The Force Fiber® Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available as 100% blue (UHMWPE), sizes 0, 1 and 2 meeting USP requirements except for oversized dis neter.
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