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FDA 510(k)

DISPOSABLE SYRINGE

K-Number: K875097 · 1988-02-16

ApplicantCalifornia Ent.
Decision Date1988-02-16
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is California Ent.. It received FDA 510(k) clearance on 1988-02-16 under 510(k) number K875097. 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 DISPOSABLE SYRINGE?

DISPOSABLE SYRINGE is a medical device that received FDA 510(k) clearance on 1988-02-16. The listed applicant is California Ent.. The 510(k) number is K875097.

When did DISPOSABLE SYRINGE receive FDA 510(k) clearance?

DISPOSABLE SYRINGE received FDA 510(k) clearance on 1988-02-16, under 510(k) number K875097.

Who is the listed applicant for DISPOSABLE SYRINGE?

The FDA 510(k) record lists California Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE SYRINGE?

The FDA product code for DISPOSABLE SYRINGE is FMF.

Related Clinical Trials

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Other records listing California Ent. 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.

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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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