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FDA 510(k)

(BRAND NAME)

K-Number: K971384 · 1997-07-01

ApplicantLong IN Time Ent. Co., Ltd.
Decision Date1997-07-01
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

(BRAND NAME) is the device name listed in this FDA 510(k) record. The listed applicant is Long IN Time Ent. Co., Ltd.. It received FDA 510(k) clearance on 1997-07-01 under 510(k) number K971384. 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 NAME)?

(BRAND NAME) is a medical device that received FDA 510(k) clearance on 1997-07-01. The listed applicant is Long IN Time Ent. Co., Ltd.. The 510(k) number is K971384.

When did (BRAND NAME) receive FDA 510(k) clearance?

(BRAND NAME) received FDA 510(k) clearance on 1997-07-01, under 510(k) number K971384.

Who is the listed applicant for (BRAND NAME)?

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

What is the FDA product code for (BRAND NAME)?

The FDA product code for (BRAND NAME) 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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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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