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FDA 510(k)

IRRIGATION/ASPIRATION INSTRUMENT

K-Number: K942306 · 1994-09-23

ApplicantMegadyne Medical Products, Inc.
Decision Date1994-09-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IRRIGATION/ASPIRATION INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Megadyne Medical Products, Inc.. It received FDA 510(k) clearance on 1994-09-23 under 510(k) number K942306. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION/ASPIRATION INSTRUMENT?

IRRIGATION/ASPIRATION INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-09-23. The listed applicant is Megadyne Medical Products, Inc.. The 510(k) number is K942306.

When did IRRIGATION/ASPIRATION INSTRUMENT receive FDA 510(k) clearance?

IRRIGATION/ASPIRATION INSTRUMENT received FDA 510(k) clearance on 1994-09-23, under 510(k) number K942306.

Who is the listed applicant for IRRIGATION/ASPIRATION INSTRUMENT?

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

What is the FDA product code for IRRIGATION/ASPIRATION INSTRUMENT?

The FDA product code for IRRIGATION/ASPIRATION INSTRUMENT is GCJ.

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Other records listing Megadyne Medical Products, Inc. as applicant

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Related Devices (Code: GCJ)

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

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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