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FDA 510(k)

REGEN SPRAY APPLICATOR,

K-Number: K122122 · 2012-11-09

ApplicantRegen Lab SA
Decision Date2012-11-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

REGEN SPRAY APPLICATOR, is the device name listed in this FDA 510(k) record. The listed applicant is Regen Lab SA. It received FDA 510(k) clearance on 2012-11-09 under 510(k) number K122122. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGEN SPRAY APPLICATOR,?

REGEN SPRAY APPLICATOR, is a medical device that received FDA 510(k) clearance on 2012-11-09. The listed applicant is Regen Lab SA. The 510(k) number is K122122.

When did REGEN SPRAY APPLICATOR, receive FDA 510(k) clearance?

REGEN SPRAY APPLICATOR, received FDA 510(k) clearance on 2012-11-09, under 510(k) number K122122.

Who is the listed applicant for REGEN SPRAY APPLICATOR,?

The FDA 510(k) record lists Regen Lab SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGEN SPRAY APPLICATOR,?

The FDA product code for REGEN SPRAY APPLICATOR, is FMF.

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Official Source

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

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