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FDA 510(k)

S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS

K-Number: K844643 · 1985-05-10

ApplicantSurgical Laser Technologies, Inc.
Decision Date1985-05-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Laser Technologies, Inc.. It received FDA 510(k) clearance on 1985-05-10 under 510(k) number K844643. 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 S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS?

S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K844643.

When did S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS receive FDA 510(k) clearance?

S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS received FDA 510(k) clearance on 1985-05-10, under 510(k) number K844643.

Who is the listed applicant for S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS?

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

What is the FDA product code for S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS?

The FDA product code for S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS is GEX. This falls under the Gastroenterology category.

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Other records listing Surgical Laser Technologies, Inc. as applicant

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Related Devices (Code: GEX)

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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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