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510(k) Data Aggregation
K Number
K032568Device Name
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
Manufacturer
Date Cleared
2004-04-29
(253 days)
Product Code
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
MED TEXTILE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BP Cuff Barrier is a disposable non-sterile device with a medical purpose, worn by the patient as a barrier to prevent contamination between patient and blood pressure cuff.
Device Description
Disposable BP Cuff Barrier 1081789, Disposable BP Cuff Barrier, Plastic Coated, 1030193
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