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FDA 510(k)

PLUME-AWAY SMOKE EVACUATION SYSTEM

K-Number: K894038 · 1989-09-28

ApplicantLaser Technologies Group, Inc.
Decision Date1989-09-28
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLUME-AWAY SMOKE EVACUATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laser Technologies Group, Inc.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894038. 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 PLUME-AWAY SMOKE EVACUATION SYSTEM?

PLUME-AWAY SMOKE EVACUATION SYSTEM is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Laser Technologies Group, Inc.. The 510(k) number is K894038.

When did PLUME-AWAY SMOKE EVACUATION SYSTEM receive FDA 510(k) clearance?

PLUME-AWAY SMOKE EVACUATION SYSTEM received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894038.

Who is the listed applicant for PLUME-AWAY SMOKE EVACUATION SYSTEM?

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

What is the FDA product code for PLUME-AWAY SMOKE EVACUATION SYSTEM?

The FDA product code for PLUME-AWAY SMOKE EVACUATION SYSTEM is FYD.

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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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