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FDA 510(k)

(BRAND NAME0 MONDAIN

K-Number: K943840 · 1994-09-06

ApplicantChan'S Plastic Manufactory Co., Ltd.
Decision Date1994-09-06
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

(BRAND NAME0 MONDAIN is the device name listed in this FDA 510(k) record. The listed applicant is Chan'S Plastic Manufactory Co., Ltd.. It received FDA 510(k) clearance on 1994-09-06 under 510(k) number K943840. 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 (BRAND NAME0 MONDAIN?

(BRAND NAME0 MONDAIN is a medical device that received FDA 510(k) clearance on 1994-09-06. The listed applicant is Chan'S Plastic Manufactory Co., Ltd.. The 510(k) number is K943840.

When did (BRAND NAME0 MONDAIN receive FDA 510(k) clearance?

(BRAND NAME0 MONDAIN received FDA 510(k) clearance on 1994-09-06, under 510(k) number K943840.

Who is the listed applicant for (BRAND NAME0 MONDAIN?

The FDA 510(k) record lists Chan'S Plastic Manufactory Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for (BRAND NAME0 MONDAIN?

The FDA product code for (BRAND NAME0 MONDAIN 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.

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

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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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