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FDA 510(k)

TOTAL

K-Number: K821054 · 1982-05-13

ApplicantAllergan, Inc.
Decision Date1982-05-13
Product CodeHPX
DecisionSubstantially Equivalent

Device Summary

TOTAL is the device name listed in this FDA 510(k) record. The listed applicant is Allergan, Inc.. It received FDA 510(k) clearance on 1982-05-13 under 510(k) number K821054. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL?

TOTAL is a medical device that received FDA 510(k) clearance on 1982-05-13. The listed applicant is Allergan, Inc.. The 510(k) number is K821054.

When did TOTAL receive FDA 510(k) clearance?

TOTAL received FDA 510(k) clearance on 1982-05-13, under 510(k) number K821054.

Who is the listed applicant for TOTAL?

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

What is the FDA product code for TOTAL?

The FDA product code for TOTAL is HPX.

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Related PubMed Literature

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.

PMID: 42481192Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.BMJ open ()PMID: 41839575A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.International journal of spine surgery ()PMID: 41209898Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty.Cureus ()PMID: 39748246Could one strategy fit all? A comparison of regulatory guidance from China, Europe, and the USA on medical device clinical evaluation throughout the total product lifecycle.Expert review of medical devices ()

Other records listing Allergan, Inc. as applicant

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K190674REFRESH RELIEVA For CONTACTSK161457XEN Glaucoma Treatment SystemK083812REFRESH OPTIVE LENS COMFORT REWETTING DROPSK051852SINGLE AMPLIFIER FOR BOTOXK014202COMPLETE BRAND MULTI-PURPOSE SOLUTIONK013479COMPLETE BRAND MULTI-PURPOSE SOLUTION

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Related Devices (Code: HPX)

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.

K955777PMMA CLASICRand Scientific Corp.K940106KERATOPLASTY SUTURING LENSVisionary Technologies of Miami, Inc.K913081MULTI-VIEW BIFOCALSCamp Contact LensesK897021MARTIN-HENSLEY SEGMENT LENSBruce W. Martin O.D. and Edward HensleyK895411OPTIKEM PMMA CONTACT LENSOptikem Polymers, Inc.K874591ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, Co.

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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