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510(k) Data Aggregation
K Number
K141606Device Name
SURGICAL GOWN
Manufacturer
Date Cleared
2014-11-17
(154 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
COBES INDUSTRIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical Gowns are 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
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K Number
K112796Device Name
SURGICAL GOWN (EO STERILIZED)
Manufacturer
Date Cleared
2013-09-12
(717 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
COBES INDUSTRIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cobes Sterile Disposable Surgical Gowns are 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
Cobes Sterile Disposable Surgical Gown Model: G200XB Series (G2001B, G2002B and G2003B) G200XG Series (G2001G, G2002G and G2003G)
| Model Series | Model | Material | Size |
|-----------------------|--------|----------|------|
| G200XB Series (Blue) | G2001B | SSMMS | L |
| | G2002B | SSMMS | XL |
| | G2003B | SSMMS | XXL |
| G200XG Series (Green) | G2001G | SMMS | L |
| | G2002G | SMMS | XL |
| | G2003G | SMMS | XXL |
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K Number
K112378Device Name
COBES SURGICAL DRAPE
Manufacturer
Date Cleared
2012-05-08
(264 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
COBES INDUSTRIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cobes Sterile Surgical Drape is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.
Device Description
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