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510(k) Data Aggregation
K Number
K041501Device Name
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
Manufacturer
GUANGZHOU FORTUNIQUE LTD.
Date Cleared
2004-11-30
(176 days)
Product Code
MMP, KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
GUANGZHOU FORTUNIQUE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact.
Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.
Device Description
Guangzhou Fortunique Drapes, Bags and Covers are made of low density polyethylene film ir various sizes and shapes for use in covering equipment. These drapes, bags and covers are offered non-sterile in bulk quantities and sterile in individual packs.
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