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FDA 510(k)

METRA PS PROCEDURE KIT

K-Number: K984600 · 1999-06-03

ApplicantInlet Medical, Inc.
Decision Date1999-06-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

METRA PS PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Inlet Medical, Inc.. It received FDA 510(k) clearance on 1999-06-03 under 510(k) number K984600. 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 METRA PS PROCEDURE KIT?

METRA PS PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 1999-06-03. The listed applicant is Inlet Medical, Inc.. The 510(k) number is K984600.

When did METRA PS PROCEDURE KIT receive FDA 510(k) clearance?

METRA PS PROCEDURE KIT received FDA 510(k) clearance on 1999-06-03, under 510(k) number K984600.

Who is the listed applicant for METRA PS PROCEDURE KIT?

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

What is the FDA product code for METRA PS PROCEDURE KIT?

The FDA product code for METRA PS PROCEDURE KIT is GCJ.

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Other records listing Inlet Medical, Inc. as applicant

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.

K923528INLET IRRIGATION/ASPIRATION VALVE AND PROBES

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

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