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FDA 510(k)

THERAPEUTIC APPARATUS, DIERKER TYPE

K-Number: K770534 · 1978-04-21

ApplicantWell Being Ent.
Decision Date1978-04-21
Product CodeKDH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THERAPEUTIC APPARATUS, DIERKER TYPE is the device name listed in this FDA 510(k) record. The listed applicant is Well Being Ent.. It received FDA 510(k) clearance on 1978-04-21 under 510(k) number K770534. The device is classified under product code KDH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPEUTIC APPARATUS, DIERKER TYPE?

THERAPEUTIC APPARATUS, DIERKER TYPE is a medical device that received FDA 510(k) clearance on 1978-04-21. The listed applicant is Well Being Ent.. The 510(k) number is K770534.

When did THERAPEUTIC APPARATUS, DIERKER TYPE receive FDA 510(k) clearance?

THERAPEUTIC APPARATUS, DIERKER TYPE received FDA 510(k) clearance on 1978-04-21, under 510(k) number K770534.

Who is the listed applicant for THERAPEUTIC APPARATUS, DIERKER TYPE?

The FDA 510(k) record lists Well Being Ent. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERAPEUTIC APPARATUS, DIERKER TYPE?

The FDA product code for THERAPEUTIC APPARATUS, DIERKER TYPE is KDH.

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Related Devices (Code: KDH)

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.

K983624GILTECH PLUS CONNECTING TUBE SETGiltech Plus, Inc.K981286SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETSArmm, Inc.K971259COMBIPORT FLUID LAVAGE DEVICEB.Braun Medical, Inc.K962850TUM-E-VACEthox Corp.K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITBallard Medical ProductsK923497FLUSHING IRRIGATION SETOrion Life Systems, Inc.

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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