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FDA 510(k)

ABBOTT GLOBE HOLDER

K-Number: K832911 · 1983-09-29

ApplicantMiami Eye Technology, Inc.
Decision Date1983-09-29
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ABBOTT GLOBE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Miami Eye Technology, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832911. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT GLOBE HOLDER?

ABBOTT GLOBE HOLDER is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Miami Eye Technology, Inc.. The 510(k) number is K832911.

When did ABBOTT GLOBE HOLDER receive FDA 510(k) clearance?

ABBOTT GLOBE HOLDER received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832911.

Who is the listed applicant for ABBOTT GLOBE HOLDER?

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

What is the FDA product code for ABBOTT GLOBE HOLDER?

The FDA product code for ABBOTT GLOBE HOLDER is HJO.

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Other records listing Miami Eye Technology, 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.

K841101CLAYMAN-PAREL CAPSULE COUPEURK832912GELENDER VACUUM FIXATION RING SYSK832996SURGICAL IOP MONITORK832997EPA AUTOMATED INFUSION POLEK831702RARE-EARTH INTRA-OCULAR MAGNET

Related Devices (Code: HJO)

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.

K262637SLIT LAMP SL-D4 (Type: LED)Topcon CorporationK253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.

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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