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FDA 510(k), K111441, UNIMAX VERESS NEEDLE
FDA 510(k), K111441, UNIMAX VERESS NEEDLE
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510(K) Number: K111441
Device Name: UNIMAX VERESS NEEDLE
Manufacturer: UNIMAX MEDICAL SYSTEMS, INC.
Device Classification Name: insufflator, laparoscopic
Regulation Number: 884.1730
Classification Product Code: HIF
Date Received: 05/24/2011
Decision Date: 08/19/2011
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: UNIMAX VERESS NEEDLE
Manufacturer: UNIMAX MEDICAL SYSTEMS, INC.
Device Classification Name: insufflator, laparoscopic
Regulation Number: 884.1730
Classification Product Code: HIF
Date Received: 05/24/2011
Decision Date: 08/19/2011
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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