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FDA 510(k)

OPHTHALMIC FLUID INJECTOR

K-Number: K882403 · 1988-09-09

ApplicantTrek Medical Products, Inc.
Decision Date1988-09-09
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC FLUID INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Trek Medical Products, Inc.. It received FDA 510(k) clearance on 1988-09-09 under 510(k) number K882403. 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 OPHTHALMIC FLUID INJECTOR?

OPHTHALMIC FLUID INJECTOR is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Trek Medical Products, Inc.. The 510(k) number is K882403.

When did OPHTHALMIC FLUID INJECTOR receive FDA 510(k) clearance?

OPHTHALMIC FLUID INJECTOR received FDA 510(k) clearance on 1988-09-09, under 510(k) number K882403.

Who is the listed applicant for OPHTHALMIC FLUID INJECTOR?

The FDA 510(k) record lists Trek Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPHTHALMIC FLUID INJECTOR?

The FDA product code for OPHTHALMIC FLUID INJECTOR is FMF.

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Other records listing Trek Medical Products, Inc. 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.

K920937COMPUTERIZED PUPILK920944FTS-200 GAS SYSTEMK900808RAPID AUTOMATIC PNEUMOPERITONEUM-IK902784FIBER OPTIC LIGHT SOURCEK895813GLAUCOMA MECHANICAL TREPHINEK875195OPHTHALMIC LIGHT PIPE PICK

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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

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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