FDA 510(k)

MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE

K-Number: K864413 · 1986-12-09

Decision Date1986-12-09

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Lasersonics, Inc.. It received FDA 510(k) clearance on 1986-12-09 under 510(k) number K864413. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE?

MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE is a medical device that received FDA 510(k) clearance on 1986-12-09. The listed applicant is Cooper Lasersonics, Inc.. The 510(k) number is K864413.

When did MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE receive FDA 510(k) clearance?

MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE received FDA 510(k) clearance on 1986-12-09, under 510(k) number K864413.

Who is the listed applicant for MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE?

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

What is the FDA product code for MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE?

The FDA product code for MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE is KNS.

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Other records listing Cooper Lasersonics, Inc. as applicant

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Related Devices (Code: KNS)

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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.