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FDA 510(k), K011488, SPIRABRUSH CX BIOPSY INSTRUMENT
FDA 510(k), K011488, SPIRABRUSH CX BIOPSY INSTRUMENT
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510(K) Number: K011488
Device Name: SPIRABRUSH CX BIOPSY INSTRUMENT
Manufacturer: TRYLON CORP.
Device Classification Name: forceps, biopsy, gynecological
Regulation Number: 884.4530
Classification Product Code: HFB
Date Received: 05/15/2001
Decision Date: 02/22/2002
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: SPIRABRUSH CX BIOPSY INSTRUMENT
Manufacturer: TRYLON CORP.
Device Classification Name: forceps, biopsy, gynecological
Regulation Number: 884.4530
Classification Product Code: HFB
Date Received: 05/15/2001
Decision Date: 02/22/2002
Regulation Medical Specialty: Obstetrics/Gynecology
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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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