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FDA 510(k)

DENTEK LD 15 LASERSYSTEM

K-Number: K974057 · 1998-04-21

ApplicantDentek Lasersystems Produktions Ges.M.B.H.
Decision Date1998-04-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DENTEK LD 15 LASERSYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentek Lasersystems Produktions Ges.M.B.H.. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K974057. 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 DENTEK LD 15 LASERSYSTEM?

DENTEK LD 15 LASERSYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Dentek Lasersystems Produktions Ges.M.B.H.. The 510(k) number is K974057.

When did DENTEK LD 15 LASERSYSTEM receive FDA 510(k) clearance?

DENTEK LD 15 LASERSYSTEM received FDA 510(k) clearance on 1998-04-21, under 510(k) number K974057.

Who is the listed applicant for DENTEK LD 15 LASERSYSTEM?

The FDA 510(k) record lists Dentek Lasersystems Produktions Ges.M.B.H. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTEK LD 15 LASERSYSTEM?

The FDA product code for DENTEK LD 15 LASERSYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Dentek Lasersystems Produktions Ges.M.B.H. 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.

K990680DENTEC LD 15 DIODE LASER

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

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