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FDA 510(k)

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

K-Number: K000420 · 2000-05-08

ApplicantRetinalabs.Com
Decision Date2000-05-08
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 is the device name listed in this FDA 510(k) record. The listed applicant is Retinalabs.Com. It received FDA 510(k) clearance on 2000-05-08 under 510(k) number K000420. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003?

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 is a medical device that received FDA 510(k) clearance on 2000-05-08. The listed applicant is Retinalabs.Com. The 510(k) number is K000420.

When did SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 receive FDA 510(k) clearance?

SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 received FDA 510(k) clearance on 2000-05-08, under 510(k) number K000420.

Who is the listed applicant for SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003?

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

What is the FDA product code for SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003?

The FDA product code for SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 is MRH.

Related Clinical Trials

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Other records listing Retinalabs.Com 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.

K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025K000418PDT DOSECALCULATOR, MODEL 80000K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESK000416TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

Related Devices (Code: MRH)

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.

K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc.K243503VIA360™ Surgical SystemNew World Medical, Inc.K232214OMNI Surgical SystemSight Sciences, Inc.K213173TrabEx ProMicrosurgical Technologies, Inc.K212797iPrime Viscodelivery SystemGlaukosK211680Streamline Surgical SystemNew World Medical, 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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