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FDA 510(k)

MODEL 545-45 LASER FOR EAR, NOSE & THROAT

K-Number: K860975 · 1986-07-18

ApplicantBritt Corp., Inc.
Decision Date1986-07-18
Product CodeEWG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL 545-45 LASER FOR EAR, NOSE & THROAT is the device name listed in this FDA 510(k) record. The listed applicant is Britt Corp., Inc.. It received FDA 510(k) clearance on 1986-07-18 under 510(k) number K860975. The device is classified under product code EWG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 545-45 LASER FOR EAR, NOSE & THROAT?

MODEL 545-45 LASER FOR EAR, NOSE & THROAT is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Britt Corp., Inc.. The 510(k) number is K860975.

When did MODEL 545-45 LASER FOR EAR, NOSE & THROAT receive FDA 510(k) clearance?

MODEL 545-45 LASER FOR EAR, NOSE & THROAT received FDA 510(k) clearance on 1986-07-18, under 510(k) number K860975.

Who is the listed applicant for MODEL 545-45 LASER FOR EAR, NOSE & THROAT?

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

What is the FDA product code for MODEL 545-45 LASER FOR EAR, NOSE & THROAT?

The FDA product code for MODEL 545-45 LASER FOR EAR, NOSE & THROAT is EWG.

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Other records listing Britt Corp., 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.

K003828VASO PRESS DVT FOOT GARMENT #VP 520K991038VASO PRESS DVT SYSTEM, MODELS VP500, VP501K974393VASO PRESS SYSTEMK860977MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATIONK860974MODEL 545-45 LASER FOR DERMA., POD., SURGICALK860277MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT

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Related Devices (Code: EWG)

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.

K924652BENSON CCA100Benson Medical Instruments Co.K870587LASERMATIC SURGILASER MODEL 5050Lasermatic OYK880428ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880427ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.K880429ILLUMINA 55 CO2 LASER SYSTEMCooper Lasersonics, Inc.K872710MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATDirected Energy, 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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