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510(k) Data Aggregation
K Number
K990253Device Name
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
Manufacturer
Date Cleared
1999-09-24
(240 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
AMBA MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Securline Operating Room Drape is a drape accessory made of synthetic material intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.
Device Description
The Securline Operating Room Camera Drape, Model #3600 is a drape accessory made of synthetic material.
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