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FDA 510(k)

LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS

K-Number: K870219 · 1987-04-16

ApplicantLem Srl.
Decision Date1987-04-16
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS is the device name listed in this FDA 510(k) record. The listed applicant is Lem Srl.. It received FDA 510(k) clearance on 1987-04-16 under 510(k) number K870219. 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 LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS?

LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS is a medical device that received FDA 510(k) clearance on 1987-04-16. The listed applicant is Lem Srl.. The 510(k) number is K870219.

When did LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS receive FDA 510(k) clearance?

LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS received FDA 510(k) clearance on 1987-04-16, under 510(k) number K870219.

Who is the listed applicant for LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS?

The FDA 510(k) record lists Lem Srl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS?

The FDA product code for LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS 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.

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Other records listing Lem Srl. as applicant

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.

K870220LEM SPECTACLE FRAMES DIFFERENT COLORS AND DESIGNS

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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