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FDA 510(k)

HEALICOLL

K-Number: K040314 · 2004-08-12

ApplicantEncoll Corp.
Decision Date2004-08-12
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

HEALICOLL is the device name listed in this FDA 510(k) record. The listed applicant is Encoll Corp.. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K040314. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALICOLL?

HEALICOLL is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Encoll Corp.. The 510(k) number is K040314.

When did HEALICOLL receive FDA 510(k) clearance?

HEALICOLL received FDA 510(k) clearance on 2004-08-12, under 510(k) number K040314.

Who is the listed applicant for HEALICOLL?

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

What is the FDA product code for HEALICOLL?

The FDA product code for HEALICOLL is KGN.

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Related Devices (Code: KGN)

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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