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FDA 510(k)

SOFT-WEAR HEADGEAR AND SAFETY MODULES

K-Number: K932761 · 1993-10-07

ApplicantProfessional Positioners, Inc.
Decision Date1993-10-07
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOFT-WEAR HEADGEAR AND SAFETY MODULES is the device name listed in this FDA 510(k) record. The listed applicant is Professional Positioners, Inc.. It received FDA 510(k) clearance on 1993-10-07 under 510(k) number K932761. 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 SOFT-WEAR HEADGEAR AND SAFETY MODULES?

SOFT-WEAR HEADGEAR AND SAFETY MODULES is a medical device that received FDA 510(k) clearance on 1993-10-07. The listed applicant is Professional Positioners, Inc.. The 510(k) number is K932761.

When did SOFT-WEAR HEADGEAR AND SAFETY MODULES receive FDA 510(k) clearance?

SOFT-WEAR HEADGEAR AND SAFETY MODULES received FDA 510(k) clearance on 1993-10-07, under 510(k) number K932761.

Who is the listed applicant for SOFT-WEAR HEADGEAR AND SAFETY MODULES?

The FDA 510(k) record lists Professional Positioners, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT-WEAR HEADGEAR AND SAFETY MODULES?

The FDA product code for SOFT-WEAR HEADGEAR AND SAFETY MODULES is DZB.

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Other records listing Professional Positioners, 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.

K943905PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMERK932298PRO'S NEO-LASTICS

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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