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FDA 510(k)

KUNG SHIN, HMEF SK203

K-Number: K032878 · 2004-09-20

ApplicantKung Shin Plastics Co., Ltd.
Decision Date2004-09-20
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KUNG SHIN, HMEF SK203 is the device name listed in this FDA 510(k) record. The listed applicant is Kung Shin Plastics Co., Ltd.. It received FDA 510(k) clearance on 2004-09-20 under 510(k) number K032878. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KUNG SHIN, HMEF SK203?

KUNG SHIN, HMEF SK203 is a medical device that received FDA 510(k) clearance on 2004-09-20. The listed applicant is Kung Shin Plastics Co., Ltd.. The 510(k) number is K032878.

When did KUNG SHIN, HMEF SK203 receive FDA 510(k) clearance?

KUNG SHIN, HMEF SK203 received FDA 510(k) clearance on 2004-09-20, under 510(k) number K032878.

Who is the listed applicant for KUNG SHIN, HMEF SK203?

The FDA 510(k) record lists Kung Shin Plastics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KUNG SHIN, HMEF SK203?

The FDA product code for KUNG SHIN, HMEF SK203 is CAH.

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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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