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FDA 510(k), K140603, ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
FDA 510(k), K140603, ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
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510(K) Number: K140603
Device Name: ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
Manufacturer: CHERYL BLAKE
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 03/10/2014
Decision Date: 07/31/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM
Manufacturer: CHERYL BLAKE
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 03/10/2014
Decision Date: 07/31/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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