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FDA 510(k)

EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES

K-Number: K062171 · 2007-05-25

ApplicantOrtho Development Corp.
Decision Date2007-05-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K062171. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES?

EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Ortho Development Corp.. The 510(k) number is K062171.

When did EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES receive FDA 510(k) clearance?

EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES received FDA 510(k) clearance on 2007-05-25, under 510(k) number K062171.

Who is the listed applicant for EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES?

The FDA 510(k) record lists Ortho Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES?

The FDA product code for EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORIES is GEI.

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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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