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510(k) Data Aggregation
K Number
K000421Device Name
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
Manufacturer
Date Cleared
2000-08-14
(188 days)
Product Code
Regulation Number
878.4460Why did this record match?
Applicant Name (Manufacturer) :
SSL AMERICAS, INC. (REGENT MEDICAL)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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