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Found 3 results
510(k) Data Aggregation
K Number
K003015Device Name
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
Manufacturer
SURGICAL SPECIALTIES CORP.
Date Cleared
2000-12-15
(79 days)
Product Code
GAN
Regulation Number
878.4830Why did this record match?
Product Code :
GAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964072Device Name
MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
Manufacturer
ETHICON, INC.
Date Cleared
1996-12-18
(68 days)
Product Code
GAN
Regulation Number
878.4830Why did this record match?
Product Code :
GAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MONOCRYL suture, undyed is intended for use in general soft tissue approximation and/or ligation.
Modified MONOCRYL sutures, undyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Device Description
MONOCRYL suture, undyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone.
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K Number
K960653Device Name
MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
Manufacturer
ETHICON, INC.
Date Cleared
1996-03-28
(42 days)
Product Code
GAN
Regulation Number
878.4830Why did this record match?
Product Code :
GAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MONOCRYL suture, dyed is intended for use in general soft tissue approximation and/or ligation.
MONOCRYL sutures, dyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Device Description
MONOCRYL suture, dyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. MONOCRYL suture is dyed violet using D&C Violet No. 2.
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