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510(k) Data Aggregation
K Number
K060471Device Name
FSSB NYLON SURGICAL SUTURES
Manufacturer
FSSB CHIRURGISCHE NADELN GMBH
Date Cleared
2006-07-26
(153 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
FSSB CHIRURGISCHE NADELN GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures.
Device Description
FSSB Nylon Surgical Suture is a monofilament non-absorbable sterile surgical suture composed of the long chain aliphatic polymers Nylon 6,6. The suture is provided dyed (black). The pigment for the black dyed suture is Hematein black (Logwood: Color Code 75290). All products meet the requirements of 21 CFR 70.5(c) regarding the use of color additives in sutures.
The product is available in several lengths and USP diameters. The FSSB Surgical Suture is equipped with single or double high-grade stainless steel needles of various types of points, lengths, diameters and curves (Product List provided as Appendix A). The product meets all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures.
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