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FDA 510(k)

SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001

K-Number: K071180 · 2007-06-20

ApplicantEngineered Medical Solutions Co., LLC
Decision Date2007-06-20
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Solutions Co., LLC. It received FDA 510(k) clearance on 2007-06-20 under 510(k) number K071180. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001?

SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 is a medical device that received FDA 510(k) clearance on 2007-06-20. The listed applicant is Engineered Medical Solutions Co., LLC. The 510(k) number is K071180.

When did SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 receive FDA 510(k) clearance?

SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 received FDA 510(k) clearance on 2007-06-20, under 510(k) number K071180.

Who is the listed applicant for SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001?

The FDA 510(k) record lists Engineered Medical Solutions Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001?

The FDA product code for SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 is FTD.

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Other records listing Engineered Medical Solutions Co., LLC 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.

K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT

Related Devices (Code: FTD)

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.

K133425SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHTEngineered Medical Solutions Co., LLCK130513VOLISTA 400; VOLISTA 600Maquet S.A.S.K123776POLARIS 100/200Drager Medical GmbHK111020ATRICURE DISSECTORAtriCure, Inc.K100234HM-LAMP IIHillusa, Inc.K100884STRYKER KNIFELIGHTHowmedica Osteonics Corp.

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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