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FDA 510(k), K042290, VACUUM ASSISTED CORE BIOPSY DEVICE
FDA 510(k), K042290, VACUUM ASSISTED CORE BIOPSY DEVICE
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510(K) Number: K042290
Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
Manufacturer: SUROS SURGICAL SYSTEMS, INC.
Device Classification Name: instrument, biopsy
Regulation Number: 876.1075
Classification Product Code: KNW
Date Received: 08/24/2004
Decision Date: 10/06/2004
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
Manufacturer: SUROS SURGICAL SYSTEMS, INC.
Device Classification Name: instrument, biopsy
Regulation Number: 876.1075
Classification Product Code: KNW
Date Received: 08/24/2004
Decision Date: 10/06/2004
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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