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FDA 510(k)

ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM

K-Number: K051304 · 2005-06-03

ApplicantScience Surgical Corporation
Decision Date2005-06-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Science Surgical Corporation. It received FDA 510(k) clearance on 2005-06-03 under 510(k) number K051304. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM?

ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-03. The listed applicant is Science Surgical Corporation. The 510(k) number is K051304.

When did ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM receive FDA 510(k) clearance?

ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM received FDA 510(k) clearance on 2005-06-03, under 510(k) number K051304.

Who is the listed applicant for ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM?

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

What is the FDA product code for ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM?

The FDA product code for ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM is IYO.

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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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