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Found 7 results
510(k) Data Aggregation
K Number
K022666Device Name
PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
Manufacturer
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
Date Cleared
2002-10-09
(61 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
Device Description
The PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and CP Medical are monofilament suture composed of a Poly(p-dioxanone) acid, un-dyed or dyed with D&C Violet No. 2.
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K Number
K022664Device Name
PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
Manufacturer
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
Date Cleared
2002-09-10
(32 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PGA (polyglycolic) Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
Device Description
The PGA (Polyglycolic) Synthetic Absorbable Sutures, U.S.P. manufactured by ARC Medical and SAMYANG Corporation are braided and monofilament types and coated with polycaprolate and calcium stearate and are un-dyed with D&C Violet No. 2.
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K Number
K000541Device Name
SILK NONABSORBABLE SURGICAL SUTURES, USP
Manufacturer
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
Date Cleared
2000-04-28
(71 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000542Device Name
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
Manufacturer
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
Date Cleared
2000-04-28
(71 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Applicant Name (Manufacturer) :
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000537Device Name
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
Manufacturer
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
Date Cleared
2000-04-27
(70 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000539Device Name
NYLON NONABSORBABLE SURGICAL SUTURES, USP
Manufacturer
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
Date Cleared
2000-04-27
(70 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000540Device Name
POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
Manufacturer
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
Date Cleared
2000-04-27
(70 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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