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510(k) Data Aggregation
K Number
K041224Device Name
FOOTHILLS SURGICAL DRAPES
Manufacturer
Date Cleared
2005-02-03
(269 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
FOOTHILLS INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.
These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.
Device Description
Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings.
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