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FDA 510(k), K061050, GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
FDA 510(k), K061050, GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
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510(K) Number: K061050
Device Name: GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
Manufacturer: ETHICON, INC.
Device Classification Name: laparoscope, gynecologic (and accessories)
Regulation Number: 884.1720
Classification Product Code: HET
Date Received: 04/17/2006
Decision Date: 07/14/2006
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
Manufacturer: ETHICON, INC.
Device Classification Name: laparoscope, gynecologic (and accessories)
Regulation Number: 884.1720
Classification Product Code: HET
Date Received: 04/17/2006
Decision Date: 07/14/2006
Regulation Medical Specialty: Obstetrics/Gynecology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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