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FDA 510(k)

DISPOSABLE PLASTIC SYRINGE W/NEEDLE

K-Number: K813223 · 1982-04-15

ApplicantSam Joo Industrial Co., Ltd.
Decision Date1982-04-15
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PLASTIC SYRINGE W/NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Sam Joo Industrial Co., Ltd.. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K813223. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE PLASTIC SYRINGE W/NEEDLE?

DISPOSABLE PLASTIC SYRINGE W/NEEDLE is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is Sam Joo Industrial Co., Ltd.. The 510(k) number is K813223.

When did DISPOSABLE PLASTIC SYRINGE W/NEEDLE receive FDA 510(k) clearance?

DISPOSABLE PLASTIC SYRINGE W/NEEDLE received FDA 510(k) clearance on 1982-04-15, under 510(k) number K813223.

Who is the listed applicant for DISPOSABLE PLASTIC SYRINGE W/NEEDLE?

The FDA 510(k) record lists Sam Joo Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE PLASTIC SYRINGE W/NEEDLE?

The FDA product code for DISPOSABLE PLASTIC SYRINGE W/NEEDLE is DXG.

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Other records listing Sam Joo Industrial 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.

K813157COLORLESS DISPOSIBLE PLASTIC SYRINGES

Related Devices (Code: DXG)

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

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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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