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FDA 510(k)

FRAMES (EYE GLASSES)

K-Number: K913046 · 1991-08-28

Decision Date1991-08-28
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FRAMES (EYE GLASSES) is the device name listed in this FDA 510(k) record. The listed applicant is Jiuh Chyi Ent. Co., Ltd.. It received FDA 510(k) clearance on 1991-08-28 under 510(k) number K913046. 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 FRAMES (EYE GLASSES)?

FRAMES (EYE GLASSES) is a medical device that received FDA 510(k) clearance on 1991-08-28. The listed applicant is Jiuh Chyi Ent. Co., Ltd.. The 510(k) number is K913046.

When did FRAMES (EYE GLASSES) receive FDA 510(k) clearance?

FRAMES (EYE GLASSES) received FDA 510(k) clearance on 1991-08-28, under 510(k) number K913046.

Who is the listed applicant for FRAMES (EYE GLASSES)?

The FDA 510(k) record lists Jiuh Chyi Ent. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRAMES (EYE GLASSES)?

The FDA product code for FRAMES (EYE GLASSES) is HQZ.

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.

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.

Official Source

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