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FDA 510(k)

NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS

K-Number: K131795 · 2013-09-26

ApplicantOrfit Industries NV
Decision Date2013-09-26
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS is the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2013-09-26 under 510(k) number K131795. 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 NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS?

NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is Orfit Industries NV. The 510(k) number is K131795.

When did NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS receive FDA 510(k) clearance?

NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS received FDA 510(k) clearance on 2013-09-26, under 510(k) number K131795.

Who is the listed applicant for NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS?

The FDA 510(k) record lists Orfit Industries NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS?

The FDA product code for NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS is IYE.

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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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