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510(k) Data Aggregation
K Number
K081001Device Name
PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
Manufacturer
SUTURES INDIA PVT., LTD.
Date Cleared
2008-06-09
(62 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PD SYNTH IS SYNTHETIC ABSORBABLE (MONOFILAMENT POLYDIOXANONE) SURGICAL SUTURE, STERILE AND FLEXIBLE STRAND, PREPARED FROM THE POLYMER, POLYDIOXANONE, (HOMO POLYMER OF DI OXANONE 100%) AND IS INDICATED FOR USE IN SOFT TISSUE APPROXIMATION, INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIO VASCULAR AND NEUROLOGICAL TISSUES
Device Description
PD Synth is a synthetic absorbable surgical suture, (Monofilament Polydioxanone). PD Synth is a sterile flexible monofilament thread, composed of the polymer, Polydioxanone. The sutures are inert, non collageneous and non antigenic. PD Synth is dyed with D&C Violet #2 and being monofilament it is uncoated
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K Number
K081002Device Name
MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE
Manufacturer
SUTURES INDIA PVT., LTD.
Date Cleared
2008-06-09
(62 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MONOGLYDE IS A SYNTHETIC ABSORBABLE (POLIGLECAPRONE 25) SURGICAL SUTURE; STERILE FLEXIBLE STRAND, PREPARED AND SYNTHESIZED FROM THE MONOMERS, POLYGLYCOLIC ACID 75% AND CAPROLACTONE 25% AND IS INDICATED FOR USE IN GENERAL SOFT TISSUE APPROXIMATION, BUT NOT FOR USE IN OPHTHALMIC SURGERY, CARDIO-VASCULAR AND NEUROLOGICAL TISSUES
Device Description
MONOGLYDE is synthetic absorbable surgical suture, (Monofilament Poliglecaprone 25). Monoglyde is a sterile flexible monofilament thread, composed of Caprolactone. The sutures are inert, non collageneous and non antigenic. MONOGLYDE is dyed with D&C Violet #2 and it is available undyed also.
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K Number
K081003Device Name
TRUSYNTH, ABSORBABLE (POLYGLACTIN 910) SUTURE
Manufacturer
SUTURES INDIA PVT., LTD.
Date Cleared
2008-06-09
(62 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K060018Device Name
TRULENE MESH
Manufacturer
SUTURES INDIA PVT., LTD.
Date Cleared
2006-07-26
(203 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
SUTURES INDIA PVT., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRULENE MESH, NONABSORBABLE POLYPROPYLENE SURGICAL MESH IS INDICATED FOR USE IN HERNIA REPAIR AND OTHER FASCIAL DEFICIENCIES THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE DESIRED SURGICAL RESULT.
Device Description
Trulene Mesh is Nonabsorbable Polypropylene Surgical Mesh, produced by knitting filaments of extruded undyed Monofilament Polypropylene, a synthetic linear Poly olefin.
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