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FDA 510(k)

ETB TROCAR SYSTEM

K-Number: K990894 · 1999-05-19

ApplicantThe Altomec Corp.
Decision Date1999-05-19
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ETB TROCAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Altomec Corp.. It received FDA 510(k) clearance on 1999-05-19 under 510(k) number K990894. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETB TROCAR SYSTEM?

ETB TROCAR SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-19. The listed applicant is The Altomec Corp.. The 510(k) number is K990894.

When did ETB TROCAR SYSTEM receive FDA 510(k) clearance?

ETB TROCAR SYSTEM received FDA 510(k) clearance on 1999-05-19, under 510(k) number K990894.

Who is the listed applicant for ETB TROCAR SYSTEM?

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

What is the FDA product code for ETB TROCAR SYSTEM?

The FDA product code for ETB TROCAR SYSTEM is GCJ.

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Other records listing The Altomec Corp. 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.

K972298ETB TELESCOPE W/WORKING CHANNEL FOR SEPS

Related Devices (Code: GCJ)

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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