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FDA 510(k)

LUNETTE MENSTRUAL CUP, MODELS 1 AND 2

K-Number: K091754 · 2009-11-13

ApplicantLune Group , Ltd.
Decision Date2009-11-13
Product CodeHHE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Lune Group , Ltd.. It received FDA 510(k) clearance on 2009-11-13 under 510(k) number K091754. The device is classified under product code HHE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNETTE MENSTRUAL CUP, MODELS 1 AND 2?

LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 2009-11-13. The listed applicant is Lune Group , Ltd.. The 510(k) number is K091754.

When did LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 receive FDA 510(k) clearance?

LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 received FDA 510(k) clearance on 2009-11-13, under 510(k) number K091754.

Who is the listed applicant for LUNETTE MENSTRUAL CUP, MODELS 1 AND 2?

The FDA 510(k) record lists Lune Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUNETTE MENSTRUAL CUP, MODELS 1 AND 2?

The FDA product code for LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 is HHE.

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Related Devices (Code: HHE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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