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FDA 510(k)

MULTI ADJUSTABLE FACE MASK

K-Number: K000358 · 2000-06-09

ApplicantOrtho Technology
Decision Date2000-06-09
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MULTI ADJUSTABLE FACE MASK is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Technology. It received FDA 510(k) clearance on 2000-06-09 under 510(k) number K000358. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI ADJUSTABLE FACE MASK?

MULTI ADJUSTABLE FACE MASK is a medical device that received FDA 510(k) clearance on 2000-06-09. The listed applicant is Ortho Technology. The 510(k) number is K000358.

When did MULTI ADJUSTABLE FACE MASK receive FDA 510(k) clearance?

MULTI ADJUSTABLE FACE MASK received FDA 510(k) clearance on 2000-06-09, under 510(k) number K000358.

Who is the listed applicant for MULTI ADJUSTABLE FACE MASK?

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

What is the FDA product code for MULTI ADJUSTABLE FACE MASK?

The FDA product code for MULTI ADJUSTABLE FACE MASK is DZB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ortho Technology 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.

K051751EQUA-PULL SAFETY RELEASE MODULE

Related Devices (Code: DZB)

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.

K202855Orthodontic FacemaskIta.O Italian Orthodontic System S.R.L.K162543Reverse Pull Adjustable FacemaskSawbros Industries Pvt., Ltd.K111169PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMFKwang Myung Daicom, Inc.K103019KJ MASKKj Meditech Co., Ltd.K052553NITOM LOCKING FACEBOWRussell Samuels Orthodontic DesignK051751EQUA-PULL SAFETY RELEASE MODULEOrtho Technology

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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