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510(k) Data Aggregation
Device Name
CAPROSYN ABSORBABLE SUTUREDate Cleared
2003-11-17
(87 days)
Product Code
Regulation Number
878.4493Type
AbbreviatedAge Range
All
Reference & Predicate Devices
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Caprosyn* synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological surgery, or microsurgery.
Device Description
Absorbable poly(glycolide/L-lactide) surgical suture
AI/ML Overview
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The documents are a brief summary of safety and effectiveness for a surgical suture and an FDA clearance letter for the same device. Therefore, I cannot provide the requested information.
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