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FDA 510(k)

SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC

K-Number: K900439 · 1990-02-15

ApplicantL H M Ent., Inc.
Decision Date1990-02-15
Product CodeFIH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC is the device name listed in this FDA 510(k) record. The listed applicant is L H M Ent., Inc.. It received FDA 510(k) clearance on 1990-02-15 under 510(k) number K900439. The device is classified under product code FIH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC?

SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC is a medical device that received FDA 510(k) clearance on 1990-02-15. The listed applicant is L H M Ent., Inc.. The 510(k) number is K900439.

When did SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC receive FDA 510(k) clearance?

SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC received FDA 510(k) clearance on 1990-02-15, under 510(k) number K900439.

Who is the listed applicant for SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC?

The FDA 510(k) record lists L H M Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC?

The FDA product code for SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC is FIH.

Related Clinical Trials

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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Other records listing L H M Ent., 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.

K901078SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINEK901079SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATERK894610CUSTOM TRAYS, KITSK894611CATHETER CARE KITSK883506IRRIGATION KIT

Related Devices (Code: FIH)

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.

K932055PERCUPUMP IIE-Z-Em, Inc.K931113CADD-TPN(TM) AMBULATORY INFUSION SYSTEMPharmacia Deltec, Inc.K935461VECTOR AMBULATORY DRUG DELIVERY SYSTEMInfusion Technology Intl.K881707INTROCULAR FLUID INJECTORB&B Medical Assoc., Inc.

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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