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510(k) Data Aggregation
K Number
K080723Device Name
SRI LP GOWN
Manufacturer
Date Cleared
2008-11-13
(246 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
SRI/SURGICAL EXPRESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SRI/Surgical Express SRI Level IV Gowns are reusable gowns that arc intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Device Description
SRI/Surgical Express Level IV Gowns
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K Number
K023635Device Name
SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN
Manufacturer
Date Cleared
2002-11-18
(20 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
SRI/SURGICAL EXPRESS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical gowns are devices that are intended to be worn by health care personnel during surgical or other Ourgiour gowns are a vice that and the wearer from transfer of microorganisms, body fluids, and particulate material.
Device Description
reusable surgical ' gown manufactured with the W.L. Gore ASSIST™ medical fabric in the Critical Zones.
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