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FDA 510(k)

REGENCY TUBE

K-Number: K936243 · 1994-02-02

ApplicantOrtho Specialties
Decision Date1994-02-02
Product CodeDZD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REGENCY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Specialties. It received FDA 510(k) clearance on 1994-02-02 under 510(k) number K936243. 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 REGENCY TUBE?

REGENCY TUBE is a medical device that received FDA 510(k) clearance on 1994-02-02. The listed applicant is Ortho Specialties. The 510(k) number is K936243.

When did REGENCY TUBE receive FDA 510(k) clearance?

REGENCY TUBE received FDA 510(k) clearance on 1994-02-02, under 510(k) number K936243.

Who is the listed applicant for REGENCY TUBE?

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

What is the FDA product code for REGENCY TUBE?

The FDA product code for REGENCY TUBE is DZD.

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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.

K943421ORTHODONITC ELASTOMERIC SLEEVINGJon-Ko Products, Inc.K935143DENTAURUM 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

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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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