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FDA 510(k)

MESIAL LOOP BAR

K-Number: K933542 · 1994-08-05

ApplicantGac Intl., Inc.
Decision Date1994-08-05
Product CodeECO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MESIAL LOOP BAR is the device name listed in this FDA 510(k) record. The listed applicant is Gac Intl., Inc.. It received FDA 510(k) clearance on 1994-08-05 under 510(k) number K933542. The device is classified under product code ECO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESIAL LOOP BAR?

MESIAL LOOP BAR is a medical device that received FDA 510(k) clearance on 1994-08-05. The listed applicant is Gac Intl., Inc.. The 510(k) number is K933542.

When did MESIAL LOOP BAR receive FDA 510(k) clearance?

MESIAL LOOP BAR received FDA 510(k) clearance on 1994-08-05, under 510(k) number K933542.

Who is the listed applicant for MESIAL LOOP BAR?

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

What is the FDA product code for MESIAL LOOP BAR?

The FDA product code for MESIAL LOOP BAR is ECO.

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Other records listing Gac Intl., 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.

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Related Devices (Code: ECO)

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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