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FDA 510(k)

ILS(TM) - INVASIVE LINE SEPARATOR

K-Number: K924369 · 1993-02-05

Applicant2-Rn Corp.
Decision Date1993-02-05
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ILS(TM) - INVASIVE LINE SEPARATOR is the device name listed in this FDA 510(k) record. The listed applicant is 2-Rn Corp.. It received FDA 510(k) clearance on 1993-02-05 under 510(k) number K924369. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILS(TM) - INVASIVE LINE SEPARATOR?

ILS(TM) - INVASIVE LINE SEPARATOR is a medical device that received FDA 510(k) clearance on 1993-02-05. The listed applicant is 2-Rn Corp.. The 510(k) number is K924369.

When did ILS(TM) - INVASIVE LINE SEPARATOR receive FDA 510(k) clearance?

ILS(TM) - INVASIVE LINE SEPARATOR received FDA 510(k) clearance on 1993-02-05, under 510(k) number K924369.

Who is the listed applicant for ILS(TM) - INVASIVE LINE SEPARATOR?

The FDA 510(k) record lists 2-Rn Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ILS(TM) - INVASIVE LINE SEPARATOR?

The FDA product code for ILS(TM) - INVASIVE LINE SEPARATOR is KMK.

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Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K981860A P HARNESSParaworks Enterprise, Ltd.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K941098SECURE-SITEOp-Co Medical Products , Ltd.K943147STATLOCK CVVenetec, Inc.K943047IV START KITSSterile Concepts, 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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