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FDA 510(k)

PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,

K-Number: K102007 · 2010-12-22

ApplicantLife-Tech, Inc.
Decision Date2010-12-22
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech, Inc.. It received FDA 510(k) clearance on 2010-12-22 under 510(k) number K102007. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,?

PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, is a medical device that received FDA 510(k) clearance on 2010-12-22. The listed applicant is Life-Tech, Inc.. The 510(k) number is K102007.

When did PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, receive FDA 510(k) clearance?

PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, received FDA 510(k) clearance on 2010-12-22, under 510(k) number K102007.

Who is the listed applicant for PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,?

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

What is the FDA product code for PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,?

The FDA product code for PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, is CAZ.

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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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