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FDA 510(k), K091754, LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
FDA 510(k), K091754, LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
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510(K) Number: K091754
Device Name: LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
Manufacturer: MORRIS WAXLER
Device Classification Name: Cup, Menstrual
Regulation Number: HHE
Classification Product Code: 06/16/2009
Date Received: 11/13/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
Device Name: LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
Manufacturer: MORRIS WAXLER
Device Classification Name: Cup, Menstrual
Regulation Number: HHE
Classification Product Code: 06/16/2009
Date Received: 11/13/2009
Decision Date: Substantially Equivalent (SESE)
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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