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FDA 510(k)

COLORLESS DISPOSIBLE PLASTIC SYRINGES

K-Number: K813157 · 1982-04-14

ApplicantSam Joo Industrial Co., Ltd.
Decision Date1982-04-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COLORLESS DISPOSIBLE PLASTIC SYRINGES 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 1982-04-14 under 510(k) number K813157. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORLESS DISPOSIBLE PLASTIC SYRINGES?

COLORLESS DISPOSIBLE PLASTIC SYRINGES is a medical device that received FDA 510(k) clearance on 1982-04-14. The listed applicant is Sam Joo Industrial Co., Ltd.. The 510(k) number is K813157.

When did COLORLESS DISPOSIBLE PLASTIC SYRINGES receive FDA 510(k) clearance?

COLORLESS DISPOSIBLE PLASTIC SYRINGES received FDA 510(k) clearance on 1982-04-14, under 510(k) number K813157.

Who is the listed applicant for COLORLESS DISPOSIBLE PLASTIC SYRINGES?

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 COLORLESS DISPOSIBLE PLASTIC SYRINGES?

The FDA product code for COLORLESS DISPOSIBLE PLASTIC SYRINGES is FMF.

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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.

K813223DISPOSABLE PLASTIC SYRINGE W/NEEDLE

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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