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FDA 510(k)

EQUALIZER

K-Number: K780617 · 1978-04-18

ApplicantBallert Orthopedic Corp.
Decision Date1978-04-18
Product CodeIPG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EQUALIZER is the device name listed in this FDA 510(k) record. The listed applicant is Ballert Orthopedic Corp.. It received FDA 510(k) clearance on 1978-04-18 under 510(k) number K780617. The device is classified under product code IPG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUALIZER?

EQUALIZER is a medical device that received FDA 510(k) clearance on 1978-04-18. The listed applicant is Ballert Orthopedic Corp.. The 510(k) number is K780617.

When did EQUALIZER receive FDA 510(k) clearance?

EQUALIZER received FDA 510(k) clearance on 1978-04-18, under 510(k) number K780617.

Who is the listed applicant for EQUALIZER?

The FDA 510(k) record lists Ballert Orthopedic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EQUALIZER?

The FDA product code for EQUALIZER is IPG.

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 Ballert Orthopedic Corp. 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.

K771988VERTETRAC

Related Devices (Code: IPG)

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.

K024279NESS CHILDREN SYSTEMNess-Neuromuscular Electrical Stimulation SystemsK790652TOGUARDTogard, Inc.K781363CAST SHOECutler BiomedicalK760575ROCKER-SOLE CAST SANDALRichard'S Medical Equip., Inc.K760578BALANCED CAST SOLEParke-Davis Co.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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