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FDA 510(k)

SELOFIX

K-Number: K821257 · 1982-05-14

ApplicantSelomas, Inc.
Decision Date1982-05-14
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SELOFIX is the device name listed in this FDA 510(k) record. The listed applicant is Selomas, Inc.. It received FDA 510(k) clearance on 1982-05-14 under 510(k) number K821257. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELOFIX?

SELOFIX is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Selomas, Inc.. The 510(k) number is K821257.

When did SELOFIX receive FDA 510(k) clearance?

SELOFIX received FDA 510(k) clearance on 1982-05-14, under 510(k) number K821257.

Who is the listed applicant for SELOFIX?

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

What is the FDA product code for SELOFIX?

The FDA product code for SELOFIX is KGX.

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 Selomas, 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.

K861215GAUZE SPONGES USP TYPE VIIK821258SELOPORK821260VITOFITK821259VITASANK821490SILKAFIX ADHESIVE PLASTERK812501OPRAFLEX

View all 7 devices →

Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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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