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FDA 510(k)

ION-IMPLANTED NEO SENTALLOY

K-Number: K932025 · 1993-09-13

ApplicantGac Intl., Inc.
Decision Date1993-09-13
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ION-IMPLANTED NEO SENTALLOY 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 1993-09-13 under 510(k) number K932025. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ION-IMPLANTED NEO SENTALLOY?

ION-IMPLANTED NEO SENTALLOY is a medical device that received FDA 510(k) clearance on 1993-09-13. The listed applicant is Gac Intl., Inc.. The 510(k) number is K932025.

When did ION-IMPLANTED NEO SENTALLOY receive FDA 510(k) clearance?

ION-IMPLANTED NEO SENTALLOY received FDA 510(k) clearance on 1993-09-13, under 510(k) number K932025.

Who is the listed applicant for ION-IMPLANTED NEO SENTALLOY?

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 ION-IMPLANTED NEO SENTALLOY?

The FDA product code for ION-IMPLANTED NEO SENTALLOY is EJF.

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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.

K981036SMARTBONDK942826ORTHODONITC METAL REINFORCED PLASTIC BRACKETK933542MESIAL LOOP BARK932825MICROARCH GOLD BRACKETK932319ORTHODONTIC ELASTOMERK920905BIOFORCE WIRE

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Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, Inc.

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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