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FDA 510(k)

STONELITH, MODEL V5

K-Number: K011106 · 2002-02-11

ApplicantPck Electronic Industry and Trade Co, Ltd.
Decision Date2002-02-11
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STONELITH, MODEL V5 is the device name listed in this FDA 510(k) record. The listed applicant is Pck Electronic Industry and Trade Co, Ltd.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K011106. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STONELITH, MODEL V5?

STONELITH, MODEL V5 is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Pck Electronic Industry and Trade Co, Ltd.. The 510(k) number is K011106.

When did STONELITH, MODEL V5 receive FDA 510(k) clearance?

STONELITH, MODEL V5 received FDA 510(k) clearance on 2002-02-11, under 510(k) number K011106.

Who is the listed applicant for STONELITH, MODEL V5?

The FDA 510(k) record lists Pck Electronic Industry and Trade Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STONELITH, MODEL V5?

The FDA product code for STONELITH, MODEL V5 is LNS.

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Other records listing Pck Electronic Industry and Trade Co, Ltd. 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.

K061350LITHODIAMOND ULTRAK053279UROVANTAGEK011311UROLOGIC

Related Devices (Code: LNS)

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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