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510(k) Data Aggregation
K Number
K030177Device Name
ORLON NONABSORABLE SURGICAL SUTURE USP
Manufacturer
Date Cleared
2003-07-21
(185 days)
Product Code
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
**SRI ORION PHARMACEUTICALS **& SUTURES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ORLON® Polyamide Nonabsorbable Needle Suture USP (Polyamide filament) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Device Description
The ORLON® NONABSORBABLE SURGICAL SUTURE USP is a polyamide suture. It is a nonabsorbable, sterile, flexible thread that is prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6. It meets all the requirements established by the United States Pharmacopoeia for nonabsorbable sutures. It is offered in the monofilament form and is dyed with an appropriate FDA listed color additive. The suture is provided uncoated and with or without a standard needle attached.
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