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FDA 510(k)

OMS INFUSION CANNULA ASSEMBLE

K-Number: K813481 · 1982-01-22

ApplicantOptical Micro Systems, Inc.
Decision Date1982-01-22
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OMS INFUSION CANNULA ASSEMBLE is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813481. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMS INFUSION CANNULA ASSEMBLE?

OMS INFUSION CANNULA ASSEMBLE is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K813481.

When did OMS INFUSION CANNULA ASSEMBLE receive FDA 510(k) clearance?

OMS INFUSION CANNULA ASSEMBLE received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813481.

Who is the listed applicant for OMS INFUSION CANNULA ASSEMBLE?

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

What is the FDA product code for OMS INFUSION CANNULA ASSEMBLE?

The FDA product code for OMS INFUSION CANNULA ASSEMBLE is HMX.

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Other records listing Optical Micro Systems, 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.

K950218OMS SLIMLINE PHACO HANDPIECEK946054DIPLOMAXK935223OPHTHALMIC SURGICAL SYSTEMK935226I/V POLEK935003ELECTRIC I/V POLE OR EIVP2K870068ASPIRATION REVERSAL CONTROL (ARC) MODULE

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Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, 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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