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FDA 510(k)

SHARPLAN SMOKE EVACUATION UNIT, MODEL 100

K-Number: K894765 · 1989-09-28

ApplicantLaser Industries , Ltd.
Decision Date1989-09-28
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Industries , Ltd.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894765. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHARPLAN SMOKE EVACUATION UNIT, MODEL 100?

SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Laser Industries , Ltd.. The 510(k) number is K894765.

When did SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 receive FDA 510(k) clearance?

SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894765.

Who is the listed applicant for SHARPLAN SMOKE EVACUATION UNIT, MODEL 100?

The FDA 510(k) record lists Laser Industries , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHARPLAN SMOKE EVACUATION UNIT, MODEL 100?

The FDA product code for SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 is FYD.

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Other records listing Laser Industries , Ltd. as applicant

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K933362SHARPLAN CO2 SURGICAL LASERK850633SHARPLAN MODEL 1060 CO/2 SURGICAL LASERK850628SHARPLAN 1040 CO/2 SURGICAL LASERK842997LASER RECTOSCOPE SET 784K832550SHARPLAN #734 LASER SURGICAL UNITK832551SHARPLAN #745 LASER SURG. UNIT

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Related Devices (Code: FYD)

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.

K240127PlumeSafe X5 Smoke Management SystemConmed CorporationK2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic CorporationK213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, 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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