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FDA 510(k)

COMBO 36

K-Number: K854257 · 1985-11-18

Decision Date1985-11-18
Product CodeFNJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMBO 36 is the device name listed in this FDA 510(k) record. The listed applicant is Kg Engineering, Inc.. It received FDA 510(k) clearance on 1985-11-18 under 510(k) number K854257. The device is classified under product code FNJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBO 36?

COMBO 36 is a medical device that received FDA 510(k) clearance on 1985-11-18. The listed applicant is Kg Engineering, Inc.. The 510(k) number is K854257.

When did COMBO 36 receive FDA 510(k) clearance?

COMBO 36 received FDA 510(k) clearance on 1985-11-18, under 510(k) number K854257.

Who is the listed applicant for COMBO 36?

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

What is the FDA product code for COMBO 36?

The FDA product code for COMBO 36 is FNJ.

Related Clinical Trials

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.

Other records listing Kg Engineering, 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.

Related Devices (Code: FNJ)

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.

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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