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FDA 510(k)

A2J MZ 44 LASER LIGHT FOR POSITIONING

K-Number: K872894 · 1987-08-12

ApplicantPrometex, Inc.
Decision Date1987-08-12
Product CodeIWE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

A2J MZ 44 LASER LIGHT FOR POSITIONING is the device name listed in this FDA 510(k) record. The listed applicant is Prometex, Inc.. It received FDA 510(k) clearance on 1987-08-12 under 510(k) number K872894. The device is classified under product code IWE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A2J MZ 44 LASER LIGHT FOR POSITIONING?

A2J MZ 44 LASER LIGHT FOR POSITIONING is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Prometex, Inc.. The 510(k) number is K872894.

When did A2J MZ 44 LASER LIGHT FOR POSITIONING receive FDA 510(k) clearance?

A2J MZ 44 LASER LIGHT FOR POSITIONING received FDA 510(k) clearance on 1987-08-12, under 510(k) number K872894.

Who is the listed applicant for A2J MZ 44 LASER LIGHT FOR POSITIONING?

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

What is the FDA product code for A2J MZ 44 LASER LIGHT FOR POSITIONING?

The FDA product code for A2J MZ 44 LASER LIGHT FOR POSITIONING is IWE.

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Other records listing Prometex, 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.

K894484AUDIOTESTER SCREENING AUDIOMETERK900068ARISTEE (RESIN, CROWN AND BRIDGES)K892710ARISTEE (TEMPORARY CROWN & BRIDGE RESIN)

Related Devices (Code: IWE)

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.

K973162DUAL RADIATION TARGETING SYSTEM DRTS DRAPEHogan & HartsonK955236GREEN TEC-2100Medtec, Inc.K954414CENTRALITE BACKPOINTERDiacor, Inc.K950293TEC-2110 GREEN LASER MODEL MT-HNGMedtec, Inc.K950112CENTRALITE(R)-DLL SERIESDiacor, Inc.K951601MED-TEC STRING RETICLE TRAYMedtec, Inc.

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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