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FDA 510(k)

GELENDER VACUUM FIXATION RING SYS

K-Number: K832912 · 1984-01-10

ApplicantMiami Eye Technology, Inc.
Decision Date1984-01-10
Product CodeHNH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

GELENDER VACUUM FIXATION RING SYS 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 1984-01-10 under 510(k) number K832912. The device is classified under product code HNH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELENDER VACUUM FIXATION RING SYS?

GELENDER VACUUM FIXATION RING SYS is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is Miami Eye Technology, Inc.. The 510(k) number is K832912.

When did GELENDER VACUUM FIXATION RING SYS receive FDA 510(k) clearance?

GELENDER VACUUM FIXATION RING SYS received FDA 510(k) clearance on 1984-01-10, under 510(k) number K832912.

Who is the listed applicant for GELENDER VACUUM FIXATION RING SYS?

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 GELENDER VACUUM FIXATION RING SYS?

The FDA product code for GELENDER VACUUM FIXATION RING SYS is HNH.

Related Clinical Trials

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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 COUPEURK832996SURGICAL IOP MONITORK832997EPA AUTOMATED INFUSION POLEK832911ABBOTT GLOBE HOLDERK831702RARE-EARTH INTRA-OCULAR MAGNET

Related Devices (Code: HNH)

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.

K912269LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RINGOcular Instruments, Inc.K912268LANDERS NOTCHED VITRECTOMY LENS RINGOcular Instruments, Inc.K912151LANDERS THREE STRUT VITRECTOMY LENS RINGOcular Instruments, Inc.K902496LANDERS VITRECTOMY LENS RING W/INFUSIONOcular Instruments, Inc.K863775RK VACUUM FIXATION RING SYSTEMAmeritek, Inc.K850991LANDERS VITRECTOMY LENS RING SYSTEMSOcular Instruments, Inc.

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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