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510(k) Data Aggregation
K Number
K020581Device Name
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
Manufacturer
MEDICAL CONCEPTS DEVELOPMENT, INC.
Date Cleared
2002-09-18
(209 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL CONCEPTS DEVELOPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use the ColoSHIELD during colonoscopy procedures to protect the clinical staff from patient secretions and to help maintain a cleaner procedural site.
Device Description
The proposed surgical drape is composed of polyethylene film and polypropylene components. The drape is a blue polyethylene sheet with an acrylic copolymer adhesive. The drape has a fluid collection pouch. The middle of the drave has a polypropylene ring approximately 5.25" in diameter. It is used to hold in place a polypropylene plate that reduces the 6.25" diameter down to 1.70" in diameter. The polypropylene plate has a thermo-plastic elastomer (TPE) feature that is molded to the 1.70" polypropylene plate aperture with a 0.375" diameter fenestration that secures. around an endoscope. Attached to the bottom of the plate is a polyethylene reservoir. This reservoir may be used to contain a water-soluble lubricant to aid in the insertion of the scope during the procedure.
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K Number
K000442Device Name
ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
Manufacturer
MEDICAL CONCEPTS DEVELOPMENT, INC.
Date Cleared
2001-04-24
(439 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL CONCEPTS DEVELOPMENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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