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FDA 510(k), K052567, ONE TRAY SEALED STERILIZATION CONTAINER
FDA 510(k), K052567, ONE TRAY SEALED STERILIZATION CONTAINER
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510(K) Number: K052567
Device Name: ONE TRAY SEALED STERILIZATION CONTAINER
Manufacturer: GAGE GARMAN
Device Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation Number: KCT
Classification Product Code: 09/19/2005
Date Received: 03/13/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: ONE TRAY SEALED STERILIZATION CONTAINER
Manufacturer: GAGE GARMAN
Device Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation Number: KCT
Classification Product Code: 09/19/2005
Date Received: 03/13/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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