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FDA 510(k)

MORALES PROTRACTION FACEMASK

K-Number: K032392 · 2003-10-22

ApplicantOrtosim, S.A. DE C.V.
Decision Date2003-10-22
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MORALES PROTRACTION FACEMASK is the device name listed in this FDA 510(k) record. The listed applicant is Ortosim, S.A. DE C.V.. It received FDA 510(k) clearance on 2003-10-22 under 510(k) number K032392. 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 MORALES PROTRACTION FACEMASK?

MORALES PROTRACTION FACEMASK is a medical device that received FDA 510(k) clearance on 2003-10-22. The listed applicant is Ortosim, S.A. DE C.V.. The 510(k) number is K032392.

When did MORALES PROTRACTION FACEMASK receive FDA 510(k) clearance?

MORALES PROTRACTION FACEMASK received FDA 510(k) clearance on 2003-10-22, under 510(k) number K032392.

Who is the listed applicant for MORALES PROTRACTION FACEMASK?

The FDA 510(k) record lists Ortosim, S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MORALES PROTRACTION FACEMASK?

The FDA product code for MORALES PROTRACTION FACEMASK is DZB.

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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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