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510(k) Data Aggregation
K Number
K012237Device Name
MERTEX-PLUS REUSABLE SURGICAL DRAPE
Manufacturer
Date Cleared
2001-10-15
(90 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
MERCAN AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sewing Source Custom Reusable Surgical Drapes, based on the both the Maxima ESD-AT and Mertex-Plus E5533-R materials, are reusable protective patient covering for isolating sites of surgical incisions from microbial or other contamination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.
Device Description
reusable protective patient covering for isolating sites of surgical incisions from microbial or other contamination.
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K Number
K012240Device Name
MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
Manufacturer
Date Cleared
2001-10-15
(90 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
MERCAN AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sewing Source O.R./Surgeon's Gowns, based on the both the Maxima ESD and Mertex-Plus E3333-R materials, are reusable gowns that 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. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.
Device Description
reusable gowns
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