FDA 510(k)

CAUTERIZATION SMOKE EVACUATOR

K-Number: K971758 · 1997-07-21

Decision Date1997-07-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

CAUTERIZATION SMOKE EVACUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technologies. It received FDA 510(k) clearance on 1997-07-21 under 510(k) number K971758. 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 CAUTERIZATION SMOKE EVACUATOR?

CAUTERIZATION SMOKE EVACUATOR is a medical device that received FDA 510(k) clearance on 1997-07-21. The listed applicant is Applied Medical Technologies. The 510(k) number is K971758.

When did CAUTERIZATION SMOKE EVACUATOR receive FDA 510(k) clearance?

CAUTERIZATION SMOKE EVACUATOR received FDA 510(k) clearance on 1997-07-21, under 510(k) number K971758.

Who is the listed applicant for CAUTERIZATION SMOKE EVACUATOR?

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

What is the FDA product code for CAUTERIZATION SMOKE EVACUATOR?

The FDA product code for CAUTERIZATION SMOKE EVACUATOR is GEI.

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Other records listing Applied Medical Technologies as applicant

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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.