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FDA 510(k)

KLARITY VACUUM BAG, KLARITY MOLD CUSHION

K-Number: K132124 · 2013-11-01

ApplicantKlarity Medical Products, LLC
Decision Date2013-11-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KLARITY VACUUM BAG, KLARITY MOLD CUSHION is the device name listed in this FDA 510(k) record. The listed applicant is Klarity Medical Products, LLC. It received FDA 510(k) clearance on 2013-11-01 under 510(k) number K132124. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLARITY VACUUM BAG, KLARITY MOLD CUSHION?

KLARITY VACUUM BAG, KLARITY MOLD CUSHION is a medical device that received FDA 510(k) clearance on 2013-11-01. The listed applicant is Klarity Medical Products, LLC. The 510(k) number is K132124.

When did KLARITY VACUUM BAG, KLARITY MOLD CUSHION receive FDA 510(k) clearance?

KLARITY VACUUM BAG, KLARITY MOLD CUSHION received FDA 510(k) clearance on 2013-11-01, under 510(k) number K132124.

Who is the listed applicant for KLARITY VACUUM BAG, KLARITY MOLD CUSHION?

The FDA 510(k) record lists Klarity Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KLARITY VACUUM BAG, KLARITY MOLD CUSHION?

The FDA product code for KLARITY VACUUM BAG, KLARITY MOLD CUSHION is IYE.

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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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