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FDA 510(k)

THERMOLYSIS GENERATOR

K-Number: K780337 · 1978-04-12

ApplicantClare, Inc.
Decision Date1978-04-12
Product CodeKCW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THERMOLYSIS GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Clare, Inc.. It received FDA 510(k) clearance on 1978-04-12 under 510(k) number K780337. The device is classified under product code KCW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOLYSIS GENERATOR?

THERMOLYSIS GENERATOR is a medical device that received FDA 510(k) clearance on 1978-04-12. The listed applicant is Clare, Inc.. The 510(k) number is K780337.

When did THERMOLYSIS GENERATOR receive FDA 510(k) clearance?

THERMOLYSIS GENERATOR received FDA 510(k) clearance on 1978-04-12, under 510(k) number K780337.

Who is the listed applicant for THERMOLYSIS GENERATOR?

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

What is the FDA product code for THERMOLYSIS GENERATOR?

The FDA product code for THERMOLYSIS GENERATOR is KCW.

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Related Devices (Code: KCW)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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