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FDA 510(k), K072230, POWERPICC SOLO
FDA 510(k), K072230, POWERPICC SOLO
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510(K) Number: K072230
Device Name: POWERPICC SOLO
Manufacturer: LYNN M KIRCHOFF
Device Classification Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation Number: LJS
Classification Product Code: KXA
Date Received: 08/10/2007
Decision Date: 10/05/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: POWERPICC SOLO
Manufacturer: LYNN M KIRCHOFF
Device Classification Name: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation Number: LJS
Classification Product Code: KXA
Date Received: 08/10/2007
Decision Date: 10/05/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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