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FDA 510(k)

SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL

K-Number: K103770 · 2011-04-21

ApplicantSyntex Healthcare Products Co., Ltd.
Decision Date2011-04-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Healthcare Products Co., Ltd.. It received FDA 510(k) clearance on 2011-04-21 under 510(k) number K103770. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL?

SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL is a medical device that received FDA 510(k) clearance on 2011-04-21. The listed applicant is Syntex Healthcare Products Co., Ltd.. The 510(k) number is K103770.

When did SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL receive FDA 510(k) clearance?

SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL received FDA 510(k) clearance on 2011-04-21, under 510(k) number K103770.

Who is the listed applicant for SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL?

The FDA 510(k) record lists Syntex Healthcare Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL?

The FDA product code for SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL is LZA.

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Related Devices (Code: LZA)

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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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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