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510(k) Data Aggregation
K Number
K945105Device Name
POLY/PLATINUM WIRE PISTON
Manufacturer
Date Cleared
1996-05-14
(574 days)
Product Code
Regulation Number
874.3450Why did this record match?
Applicant Name (Manufacturer) :
MICROMED DEVELOPMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Poly/Platinum Pistons are intended for the elective reconstruction of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prosthesis is implanted into the middle ear during a tympanoplasty procedure and is retained in the middle ear by the design configuration of the device.
Device Description
Poly/Platinum Pistons are implants for middle ear reconstruction. Available in a range of shaft diameters and lengths with loops for ossicular attachment. The device is a single patient use only implant, labeled as a restricted device for use only by a qualified health care professional and is individually sterile packaged, contained in a carton provided with an Important Product Information insert for the physician.
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