FDA 510(k)

NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES

K-Number: K941053 · 1994-07-12

Decision Date1994-07-12

Product CodeHQY

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES is the device name listed in this FDA 510(k) record. The listed applicant is Hsin Chen Intl. Co., Ltd.. It received FDA 510(k) clearance on 1994-07-12 under 510(k) number K941053. 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 NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES?

NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES is a medical device that received FDA 510(k) clearance on 1994-07-12. The listed applicant is Hsin Chen Intl. Co., Ltd.. The 510(k) number is K941053.

When did NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES receive FDA 510(k) clearance?

NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES received FDA 510(k) clearance on 1994-07-12, under 510(k) number K941053.

Who is the listed applicant for NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES?

The FDA 510(k) record lists Hsin Chen Intl. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES?

The FDA product code for NON-PRESCRIPTION SUNGLASSES W/METAL & PLASTIC FRAMES is HQY.

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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.