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510(k) Data Aggregation
K Number
K012105Device Name
POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
Manufacturer
SYMMETRY MEDICAL, INC.
Date Cleared
2002-08-02
(393 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
SYMMETRY MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used. PolyVac's delivery systems are to be sterilized in one of the following cycles: Prevacuum Steam : 132°C - 4 minutes minimum; Gravity Steam: 132°C - 30 minutes minimum; Gravity Steam: 121°C - 55 minutes minimum
Device Description
PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use. The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.
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