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FDA 510(k)

LM-300TWIN

K-Number: K913135 · 1991-09-18

ApplicantLeisegang Medical, Inc.
Decision Date1991-09-18
Product CodeFSW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LM-300TWIN is the device name listed in this FDA 510(k) record. The listed applicant is Leisegang Medical, Inc.. It received FDA 510(k) clearance on 1991-09-18 under 510(k) number K913135. The device is classified under product code FSW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LM-300TWIN?

LM-300TWIN is a medical device that received FDA 510(k) clearance on 1991-09-18. The listed applicant is Leisegang Medical, Inc.. The 510(k) number is K913135.

When did LM-300TWIN receive FDA 510(k) clearance?

LM-300TWIN received FDA 510(k) clearance on 1991-09-18, under 510(k) number K913135.

Who is the listed applicant for LM-300TWIN?

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

What is the FDA product code for LM-300TWIN?

The FDA product code for LM-300TWIN is FSW.

Other records listing Leisegang Medical, 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.

K990043SMOOTHLASE ALEXANDRITE LASER SYSTEMK940094COLPOSCOPES AND ACCESSORIESK924134LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESSK920217MAX-E-VACK914201LM- LAP 10 HIGH FLOW INSUFFLATORK912789LM-100/200LOW FLOW INSUFFLATOR

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Related Devices (Code: FSW)

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.

K022989RADLITE TISSUE RETRACTOR SYSTEMGenzyme BiosurgeryK013511XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)Aculux, Inc.K943342MEDICAM XENON LIGHT SOURCEM.P. Video, Inc.K934337CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCECuda Products Co.K922279ILLUMINATOR IV MINOR SURGERY LIGHTMedical Illumination, Inc.K894319MEDICAL DYNAMICS LIGHT SOURCEMedical Dynamics, Inc.

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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