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FDA 510(k), K003102, PARE ENDOSCOPIC SUTURING SYSTEM
FDA 510(k), K003102, PARE ENDOSCOPIC SUTURING SYSTEM
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510(K) Number: K003102
Device Name: PARE ENDOSCOPIC SUTURING SYSTEM
Manufacturer: PARE SURGICAL, INC.
Device Classification Name: endoscopic tissue approximation device
Regulation Number: 876.1500
Classification Product Code: OCW
Date Received: 10/04/2000
Decision Date: 02/27/2001
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PARE ENDOSCOPIC SUTURING SYSTEM
Manufacturer: PARE SURGICAL, INC.
Device Classification Name: endoscopic tissue approximation device
Regulation Number: 876.1500
Classification Product Code: OCW
Date Received: 10/04/2000
Decision Date: 02/27/2001
Regulation Medical Specialty: Gastroenterology/Urology
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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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