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FDA 510(k)

SURGIN IRRIGATION PUMP

K-Number: K942641 · 1994-07-07

ApplicantSurgin Surgical Instrumentation, Inc.
Decision Date1994-07-07
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURGIN IRRIGATION PUMP 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 1994-07-07 under 510(k) number K942641. 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 SURGIN IRRIGATION PUMP?

SURGIN IRRIGATION PUMP is a medical device that received FDA 510(k) clearance on 1994-07-07. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K942641.

When did SURGIN IRRIGATION PUMP receive FDA 510(k) clearance?

SURGIN IRRIGATION PUMP received FDA 510(k) clearance on 1994-07-07, under 510(k) number K942641.

Who is the listed applicant for SURGIN IRRIGATION PUMP?

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 SURGIN IRRIGATION PUMP?

The FDA product code for SURGIN IRRIGATION PUMP is GCJ.

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Other records listing Surgin Surgical Instrumentation, Inc. as applicant

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Related Devices (Code: GCJ)

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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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