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FDA 510(k), K083415, PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
FDA 510(k), K083415, PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
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510(K) Number: K083415
Device Name: PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
Manufacturer: PEAK SURGICAL, INC.
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 11/18/2008
Decision Date: 06/05/2009
Regulation Medical Specialty: General & Plastic Surgery
Device Name: PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
Manufacturer: PEAK SURGICAL, INC.
Device Classification Name: electrosurgical, cutting & coagulation & accessories
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 11/18/2008
Decision Date: 06/05/2009
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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