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FDA 510(k)

PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440

K-Number: K082180 · 2008-12-17

ApplicantAngelus Industria DE Productos Odontologicos
Decision Date2008-12-17
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 is the device name listed in this FDA 510(k) record. The listed applicant is Angelus Industria DE Productos Odontologicos. It received FDA 510(k) clearance on 2008-12-17 under 510(k) number K082180. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440?

PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is Angelus Industria DE Productos Odontologicos. The 510(k) number is K082180.

When did PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 receive FDA 510(k) clearance?

PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 received FDA 510(k) clearance on 2008-12-17, under 510(k) number K082180.

Who is the listed applicant for PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440?

The FDA 510(k) record lists Angelus Industria DE Productos Odontologicos as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440?

The FDA product code for PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 is EBI.

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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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