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FDA 510(k)

NEVONI CLASSIC, MODEL 6600-PO

K-Number: K082878 · 2008-12-30

ApplicantNsr Comercio E Representacoes Ltda
Decision Date2008-12-30
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEVONI CLASSIC, MODEL 6600-PO is the device name listed in this FDA 510(k) record. The listed applicant is Nsr Comercio E Representacoes Ltda. It received FDA 510(k) clearance on 2008-12-30 under 510(k) number K082878. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEVONI CLASSIC, MODEL 6600-PO?

NEVONI CLASSIC, MODEL 6600-PO is a medical device that received FDA 510(k) clearance on 2008-12-30. The listed applicant is Nsr Comercio E Representacoes Ltda. The 510(k) number is K082878.

When did NEVONI CLASSIC, MODEL 6600-PO receive FDA 510(k) clearance?

NEVONI CLASSIC, MODEL 6600-PO received FDA 510(k) clearance on 2008-12-30, under 510(k) number K082878.

Who is the listed applicant for NEVONI CLASSIC, MODEL 6600-PO?

The FDA 510(k) record lists Nsr Comercio E Representacoes Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEVONI CLASSIC, MODEL 6600-PO?

The FDA product code for NEVONI CLASSIC, MODEL 6600-PO is CAF.

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Official Source

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