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FDA 510(k)

BAERVELT PARS PLANA GLAUCOMA IMPLANT

K-Number: K955455 · 1997-02-18

ApplicantPharmacia Iovision, Inc.
Decision Date1997-02-18
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BAERVELT PARS PLANA GLAUCOMA IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Iovision, Inc.. It received FDA 510(k) clearance on 1997-02-18 under 510(k) number K955455. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAERVELT PARS PLANA GLAUCOMA IMPLANT?

BAERVELT PARS PLANA GLAUCOMA IMPLANT is a medical device that received FDA 510(k) clearance on 1997-02-18. The listed applicant is Pharmacia Iovision, Inc.. The 510(k) number is K955455.

When did BAERVELT PARS PLANA GLAUCOMA IMPLANT receive FDA 510(k) clearance?

BAERVELT PARS PLANA GLAUCOMA IMPLANT received FDA 510(k) clearance on 1997-02-18, under 510(k) number K955455.

Who is the listed applicant for BAERVELT PARS PLANA GLAUCOMA IMPLANT?

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

What is the FDA product code for BAERVELT PARS PLANA GLAUCOMA IMPLANT?

The FDA product code for BAERVELT PARS PLANA GLAUCOMA IMPLANT is KYF.

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Related Devices (Code: KYF)

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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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