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FDA 510(k), K122660, RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
FDA 510(k), K122660, RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
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510(K) Number: K122660
Device Name: RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Manufacturer: Boston Scientific Corporation
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 08/31/2012
Decision Date: 12/03/2012
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
Manufacturer: Boston Scientific Corporation
Device Classification Name: hemostatic metal clip for the gi tract
Regulation Number: 876.4400
Classification Product Code: PKL
Date Received: 08/31/2012
Decision Date: 12/03/2012
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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