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FDA 510(k)

NEWLIFE SCIENCES LLC, MODEL TMR

K-Number: K070474 · 2007-04-25

ApplicantNewlife Sciences, LLC
Decision Date2007-04-25
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEWLIFE SCIENCES LLC, MODEL TMR is the device name listed in this FDA 510(k) record. The listed applicant is Newlife Sciences, LLC. It received FDA 510(k) clearance on 2007-04-25 under 510(k) number K070474. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEWLIFE SCIENCES LLC, MODEL TMR?

NEWLIFE SCIENCES LLC, MODEL TMR is a medical device that received FDA 510(k) clearance on 2007-04-25. The listed applicant is Newlife Sciences, LLC. The 510(k) number is K070474.

When did NEWLIFE SCIENCES LLC, MODEL TMR receive FDA 510(k) clearance?

NEWLIFE SCIENCES LLC, MODEL TMR received FDA 510(k) clearance on 2007-04-25, under 510(k) number K070474.

Who is the listed applicant for NEWLIFE SCIENCES LLC, MODEL TMR?

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

What is the FDA product code for NEWLIFE SCIENCES LLC, MODEL TMR?

The FDA product code for NEWLIFE SCIENCES LLC, MODEL TMR is GZJ.

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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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