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FDA 510(k), K061180, KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
FDA 510(k), K061180, KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
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510(K) Number: K061180
Device Name: KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
Manufacturer: JAMES LEE
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: 04/27/2006
Date Received: 07/27/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
Manufacturer: JAMES LEE
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: 04/27/2006
Date Received: 07/27/2006
Decision Date: Substantially Equivalent (SESE)
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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