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FDA 510(k), K080525, COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
FDA 510(k), K080525, COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
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510(K) Number: K080525
Device Name: COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
Manufacturer: COOK UROLOGICAL, INC.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 02/26/2008
Decision Date: 04/17/2008
Regulation Medical Specialty: General & Plastic Surgery
Device Name: COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
Manufacturer: COOK UROLOGICAL, INC.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 02/26/2008
Decision Date: 04/17/2008
Regulation Medical Specialty: General & Plastic Surgery
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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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