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510(k) Data Aggregation
K Number
K990432Device Name
SURGISORB
Manufacturer
Date Cleared
1999-05-27
(105 days)
Product Code
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SUTURES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgisorb is indicated for use in general tissue approximation and or ligation, including use in ophthalmic procedures but not for use in cardiac or neurological procedures.
Device Description
Not Found
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K Number
K953609Device Name
PRODEK
Manufacturer
Date Cleared
1996-01-31
(182 days)
Product Code
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
SUTURES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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