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FDA 510(k)

ELITE COLLECTION

K-Number: K936149 · 1994-02-22

ApplicantOmega Group, Inc.
Decision Date1994-02-22
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ELITE COLLECTION is the device name listed in this FDA 510(k) record. The listed applicant is Omega Group, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K936149. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITE COLLECTION?

ELITE COLLECTION is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Omega Group, Inc.. The 510(k) number is K936149.

When did ELITE COLLECTION receive FDA 510(k) clearance?

ELITE COLLECTION received FDA 510(k) clearance on 1994-02-22, under 510(k) number K936149.

Who is the listed applicant for ELITE COLLECTION?

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

What is the FDA product code for ELITE COLLECTION?

The FDA product code for ELITE COLLECTION is HQZ.

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Related Devices (Code: HQZ)

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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