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FDA 510(k)

ORTHODONITC ELASTOMERIC SLEEVING

K-Number: K943421 · 1995-05-23

ApplicantJon-Ko Products, Inc.
Decision Date1995-05-23
Product CodeDZD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONITC ELASTOMERIC SLEEVING is the device name listed in this FDA 510(k) record. The listed applicant is Jon-Ko Products, Inc.. It received FDA 510(k) clearance on 1995-05-23 under 510(k) number K943421. The device is classified under product code DZD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONITC ELASTOMERIC SLEEVING?

ORTHODONITC ELASTOMERIC SLEEVING is a medical device that received FDA 510(k) clearance on 1995-05-23. The listed applicant is Jon-Ko Products, Inc.. The 510(k) number is K943421.

When did ORTHODONITC ELASTOMERIC SLEEVING receive FDA 510(k) clearance?

ORTHODONITC ELASTOMERIC SLEEVING received FDA 510(k) clearance on 1995-05-23, under 510(k) number K943421.

Who is the listed applicant for ORTHODONITC ELASTOMERIC SLEEVING?

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

What is the FDA product code for ORTHODONITC ELASTOMERIC SLEEVING?

The FDA product code for ORTHODONITC ELASTOMERIC SLEEVING is DZD.

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Other records listing Jon-Ko Products, 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.

K943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEK943417ORTHODONTIC ELASTOMERIC TUBE/THREADK943420ORTHODONTIC ELASTOMERIC CHAINK943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULE

Related Devices (Code: DZD)

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.

K936243REGENCY TUBEOrtho SpecialtiesK935143DENTAURUM STAINLESS STEEL TUBINGDentauraum, Inc.K911399NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)Aequitron Medical, Inc.K896586RATE INCREASE FOR IPPB/IPVPercussionaire Corp.K834446ALEXOTEK LINGUAL TUBESAlexotek Co.K834392LABIAL CUSPID TUBEAlexotek 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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