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FDA 510(k)

OMS SILICONE OIL INJECTOR

K-Number: K844895 · 1985-06-24

ApplicantOptical Micro Systems, Inc.
Decision Date1985-06-24
Product CodeLWL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OMS SILICONE OIL INJECTOR 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 1985-06-24 under 510(k) number K844895. The device is classified under product code LWL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMS SILICONE OIL INJECTOR?

OMS SILICONE OIL INJECTOR is a medical device that received FDA 510(k) clearance on 1985-06-24. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K844895.

When did OMS SILICONE OIL INJECTOR receive FDA 510(k) clearance?

OMS SILICONE OIL INJECTOR received FDA 510(k) clearance on 1985-06-24, under 510(k) number K844895.

Who is the listed applicant for OMS SILICONE OIL INJECTOR?

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 SILICONE OIL INJECTOR?

The FDA product code for OMS SILICONE OIL INJECTOR is LWL.

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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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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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