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FDA 510(k)

HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)

K-Number: K063498 · 2007-06-11

ApplicantSebia
Decision Date2007-06-11
Product CodeOBZ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2007-06-11 under 510(k) number K063498. The device is classified under product code OBZ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)?

HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) is a medical device that received FDA 510(k) clearance on 2007-06-11. The listed applicant is Sebia. The 510(k) number is K063498.

When did HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) receive FDA 510(k) clearance?

HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) received FDA 510(k) clearance on 2007-06-11, under 510(k) number K063498.

Who is the listed applicant for HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)?

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

What is the FDA product code for HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)?

The FDA product code for HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) is OBZ.

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Related Devices (Code: OBZ)

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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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