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FDA 510(k)

ERGO IRRIGATION SYSTEM

K-Number: K802595 · 1980-11-12

ApplicantErgo Instruments, Inc.
Decision Date1980-11-12
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ERGO IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ergo Instruments, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802595. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGO IRRIGATION SYSTEM?

ERGO IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Ergo Instruments, Inc.. The 510(k) number is K802595.

When did ERGO IRRIGATION SYSTEM receive FDA 510(k) clearance?

ERGO IRRIGATION SYSTEM received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802595.

Who is the listed applicant for ERGO IRRIGATION SYSTEM?

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

What is the FDA product code for ERGO IRRIGATION SYSTEM?

The FDA product code for ERGO IRRIGATION SYSTEM is EFS.

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Related Devices (Code: EFS)

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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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