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510(k) Data Aggregation
K Number
K091462Device Name
SPECTRA MEDICAL SAFETY SCAPEL
Manufacturer
Date Cleared
2009-12-15
(211 days)
Regulation Number
878.4800Why did this record match?
Product Code :
GDZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spectra Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.
Device Description
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