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FDA 510(k), K073671, PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
FDA 510(k), K073671, PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
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510(K) Number: K073671
Device Name: PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
Manufacturer: NDO SURGICAL, INC.
Device Classification Name: endoscopic tissue approximation device
Regulation Number: 876.1500
Classification Product Code: OCW
Date Received: 12/27/2007
Decision Date: 03/26/2008
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
Manufacturer: NDO SURGICAL, INC.
Device Classification Name: endoscopic tissue approximation device
Regulation Number: 876.1500
Classification Product Code: OCW
Date Received: 12/27/2007
Decision Date: 03/26/2008
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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