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FDA 510(k)

PERIOGENIX

K-Number: K083516 · 2009-02-20

ApplicantOroscience, Inc.
Decision Date2009-02-20
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERIOGENIX is the device name listed in this FDA 510(k) record. The listed applicant is Oroscience, Inc.. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K083516. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIOGENIX?

PERIOGENIX is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Oroscience, Inc.. The 510(k) number is K083516.

When did PERIOGENIX receive FDA 510(k) clearance?

PERIOGENIX received FDA 510(k) clearance on 2009-02-20, under 510(k) number K083516.

Who is the listed applicant for PERIOGENIX?

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

What is the FDA product code for PERIOGENIX?

The FDA product code for PERIOGENIX is EMA.

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Other records listing Oroscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082445CURATIVE980 DIODE LASER

Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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