Laboratory Test Request

USA FDA 510K ENT Endoscope Protective Sheath Testing

Project Description

USA LABORATORY (Northeast preferred)
URGENT
FDA GMP Medical Device Laboratory needed for ENT endoscope protective sheath testing for a 510K. We are looking for a lab that can perform testing following FDA guidance on a ENT endoscope protective sheath. The guidance requires microbiology or virology testing as per the following:
Guidance for Manufacturers
Seeking Marketing Clearance
of Ear, Nose, and Throat
Endoscope Sheaths Used as
Protective Barriers
Document issued on: March 12, 2000

Project Information

Number:20-02416

Industry:Medical Devices

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