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FDA 510(k)

OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR

K-Number: K051700 · 2005-08-15

Decision Date2005-08-15
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medchannel, LLC. It received FDA 510(k) clearance on 2005-08-15 under 510(k) number K051700. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR?

OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR is a medical device that received FDA 510(k) clearance on 2005-08-15. The listed applicant is Medchannel, LLC. The 510(k) number is K051700.

When did OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR receive FDA 510(k) clearance?

OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR received FDA 510(k) clearance on 2005-08-15, under 510(k) number K051700.

Who is the listed applicant for OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR?

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

What is the FDA product code for OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR?

The FDA product code for OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR is GAM.

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.

Other records listing Medchannel, LLC 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.

Related Devices (Code: GAM)

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.

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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