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FDA 510(k)

SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR

K-Number: K944312 · 1994-11-22

ApplicantShelin International Ent., Inc.
Decision Date1994-11-22
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR is the device name listed in this FDA 510(k) record. The listed applicant is Shelin International Ent., Inc.. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K944312. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR?

SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Shelin International Ent., Inc.. The 510(k) number is K944312.

When did SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR receive FDA 510(k) clearance?

SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR received FDA 510(k) clearance on 1994-11-22, under 510(k) number K944312.

Who is the listed applicant for SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR?

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

What is the FDA product code for SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR?

The FDA product code for SHELIN INTERNATIONAL ENTERPRISES, INC. EYEWEAR is HQY.

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Related Devices (Code: HQY)

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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