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FDA 510(k)

GAC THUMB-SUCKING CONTROL APPLIANCE

K-Number: K920850 · 1992-08-24

ApplicantGac Intl., Inc.
Decision Date1992-08-24
Product CodeDZC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GAC THUMB-SUCKING CONTROL APPLIANCE 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 1992-08-24 under 510(k) number K920850. The device is classified under product code DZC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAC THUMB-SUCKING CONTROL APPLIANCE?

GAC THUMB-SUCKING CONTROL APPLIANCE is a medical device that received FDA 510(k) clearance on 1992-08-24. The listed applicant is Gac Intl., Inc.. The 510(k) number is K920850.

When did GAC THUMB-SUCKING CONTROL APPLIANCE receive FDA 510(k) clearance?

GAC THUMB-SUCKING CONTROL APPLIANCE received FDA 510(k) clearance on 1992-08-24, under 510(k) number K920850.

Who is the listed applicant for GAC THUMB-SUCKING CONTROL APPLIANCE?

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 GAC THUMB-SUCKING CONTROL APPLIANCE?

The FDA product code for GAC THUMB-SUCKING CONTROL APPLIANCE is DZC.

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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 ELASTOMERK932025ION-IMPLANTED NEO SENTALLOY

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Related Devices (Code: DZC)

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.

K112640HYPERELASTIC WIREOrmco Corp.K943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KITJay H. GellerK935638NITINOL, NITIHighland MetalsK935140DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.K935142DENTAURUM WIRESDentauraum, Inc.K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREFlexmedics

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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