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FDA 510(k)

MODEL 545-45 LASER FOR DERMA., POD., SURGICAL

K-Number: K860974 · 1986-07-07

ApplicantBritt Corp., Inc.
Decision Date1986-07-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 545-45 LASER FOR DERMA., POD., SURGICAL 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 1986-07-07 under 510(k) number K860974. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 545-45 LASER FOR DERMA., POD., SURGICAL?

MODEL 545-45 LASER FOR DERMA., POD., SURGICAL is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is Britt Corp., Inc.. The 510(k) number is K860974.

When did MODEL 545-45 LASER FOR DERMA., POD., SURGICAL receive FDA 510(k) clearance?

MODEL 545-45 LASER FOR DERMA., POD., SURGICAL received FDA 510(k) clearance on 1986-07-07, under 510(k) number K860974.

Who is the listed applicant for MODEL 545-45 LASER FOR DERMA., POD., SURGICAL?

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 DERMA., POD., SURGICAL?

The FDA product code for MODEL 545-45 LASER FOR DERMA., POD., SURGICAL is GEX. This falls under the Gastroenterology category.

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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 APPLICATIONK860975MODEL 545-45 LASER FOR EAR, NOSE & THROATK860277MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT

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Related Devices (Code: GEX)

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.

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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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