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FDA 510(k)

A-COMPANY ESPREE SAFETY HEADGEAR

K-Number: K852670 · 1985-07-31

ApplicantA Company, Inc.
Decision Date1985-07-31
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

A-COMPANY ESPREE SAFETY HEADGEAR is the device name listed in this FDA 510(k) record. The listed applicant is A Company, Inc.. It received FDA 510(k) clearance on 1985-07-31 under 510(k) number K852670. 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 A-COMPANY ESPREE SAFETY HEADGEAR?

A-COMPANY ESPREE SAFETY HEADGEAR is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is A Company, Inc.. The 510(k) number is K852670.

When did A-COMPANY ESPREE SAFETY HEADGEAR receive FDA 510(k) clearance?

A-COMPANY ESPREE SAFETY HEADGEAR received FDA 510(k) clearance on 1985-07-31, under 510(k) number K852670.

Who is the listed applicant for A-COMPANY ESPREE SAFETY HEADGEAR?

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

What is the FDA product code for A-COMPANY ESPREE SAFETY HEADGEAR?

The FDA product code for A-COMPANY ESPREE SAFETY HEADGEAR is DZB.

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Other records listing A Company, Inc. as applicant

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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

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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