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FDA 510(k)

LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH

K-Number: K953243 · 1995-08-28

ApplicantDevmed Group, Inc.
Decision Date1995-08-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Devmed Group, Inc.. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K953243. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH?

LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Devmed Group, Inc.. The 510(k) number is K953243.

When did LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH receive FDA 510(k) clearance?

LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH received FDA 510(k) clearance on 1995-08-28, under 510(k) number K953243.

Who is the listed applicant for LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH?

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

What is the FDA product code for LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH?

The FDA product code for LAP WASH SYSTEM: REUSEABLE LENS WASHER & IRRIGATING SHEATH is GCJ.

Related Clinical Trials

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.

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Other records listing Devmed Group, 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.

K952723DEVMED REUSEABLE TROCAR SYSTEM

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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