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FDA 510(k)

ITEM # 755 HOT SUNGLASSES

K-Number: K931055 · 1993-10-01

Decision Date1993-10-01
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ITEM # 755 HOT SUNGLASSES is the device name listed in this FDA 510(k) record. The listed applicant is South American Industrial Co.. It received FDA 510(k) clearance on 1993-10-01 under 510(k) number K931055. 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 ITEM # 755 HOT SUNGLASSES?

ITEM # 755 HOT SUNGLASSES is a medical device that received FDA 510(k) clearance on 1993-10-01. The listed applicant is South American Industrial Co.. The 510(k) number is K931055.

When did ITEM # 755 HOT SUNGLASSES receive FDA 510(k) clearance?

ITEM # 755 HOT SUNGLASSES received FDA 510(k) clearance on 1993-10-01, under 510(k) number K931055.

Who is the listed applicant for ITEM # 755 HOT SUNGLASSES?

The FDA 510(k) record lists South American Industrial Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITEM # 755 HOT SUNGLASSES?

The FDA product code for ITEM # 755 HOT SUNGLASSES is HQY.

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: 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.

Official Source

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