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FDA 510(k)

IRRIGATION/BIPOLAR SET

K-Number: K942944 · 1994-09-27

ApplicantSurgin Surgical Instrumentation, Inc.
Decision Date1994-09-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IRRIGATION/BIPOLAR SET is the device name listed in this FDA 510(k) record. The listed applicant is Surgin Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1994-09-27 under 510(k) number K942944. 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 IRRIGATION/BIPOLAR SET?

IRRIGATION/BIPOLAR SET is a medical device that received FDA 510(k) clearance on 1994-09-27. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K942944.

When did IRRIGATION/BIPOLAR SET receive FDA 510(k) clearance?

IRRIGATION/BIPOLAR SET received FDA 510(k) clearance on 1994-09-27, under 510(k) number K942944.

Who is the listed applicant for IRRIGATION/BIPOLAR SET?

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

What is the FDA product code for IRRIGATION/BIPOLAR SET?

The FDA product code for IRRIGATION/BIPOLAR SET is GEI.

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Other records listing Surgin Surgical Instrumentation, Inc. as applicant

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Related Devices (Code: 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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