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FDA 510(k)

LOFRIC PRIMO, LOFRIC HYDRO-KIT

K-Number: K122078 · 2012-10-31

ApplicantAstra Tech, Inc.
Decision Date2012-10-31
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOFRIC PRIMO, LOFRIC HYDRO-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Astra Tech, Inc.. It received FDA 510(k) clearance on 2012-10-31 under 510(k) number K122078. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOFRIC PRIMO, LOFRIC HYDRO-KIT?

LOFRIC PRIMO, LOFRIC HYDRO-KIT is a medical device that received FDA 510(k) clearance on 2012-10-31. The listed applicant is Astra Tech, Inc.. The 510(k) number is K122078.

When did LOFRIC PRIMO, LOFRIC HYDRO-KIT receive FDA 510(k) clearance?

LOFRIC PRIMO, LOFRIC HYDRO-KIT received FDA 510(k) clearance on 2012-10-31, under 510(k) number K122078.

Who is the listed applicant for LOFRIC PRIMO, LOFRIC HYDRO-KIT?

The FDA 510(k) record lists Astra Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOFRIC PRIMO, LOFRIC HYDRO-KIT?

The FDA product code for LOFRIC PRIMO, LOFRIC HYDRO-KIT is EZD.

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Related Devices (Code: EZD)

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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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