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FDA 510(k)

SURGISIS OCULAR GRAFT

K-Number: K053622 · 2006-03-15

ApplicantIop, Inc.
Decision Date2006-03-15
Product CodeNXM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURGISIS OCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Iop, Inc.. It received FDA 510(k) clearance on 2006-03-15 under 510(k) number K053622. The device is classified under product code NXM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGISIS OCULAR GRAFT?

SURGISIS OCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2006-03-15. The listed applicant is Iop, Inc.. The 510(k) number is K053622.

When did SURGISIS OCULAR GRAFT receive FDA 510(k) clearance?

SURGISIS OCULAR GRAFT received FDA 510(k) clearance on 2006-03-15, under 510(k) number K053622.

Who is the listed applicant for SURGISIS OCULAR GRAFT?

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

What is the FDA product code for SURGISIS OCULAR GRAFT?

The FDA product code for SURGISIS OCULAR GRAFT is NXM.

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Other records listing Iop, 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.

K090078KERASYS BIOENGINEERED LAMELLAR PATCH GRAFTK062252MOLTENO3K010852OSMED TISSUE EXPANDERK003646SUTUREGROOVE WEIGHT SIZING SETK994289SUTUREGROOVEK972143MOA BONE / M-SPHERE

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Related Devices (Code: NXM)

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.

K090078KERASYS BIOENGINEERED LAMELLAR PATCH GRAFTIop, Inc.

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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