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FDA 510(k)

MEDPOR OCULAR CONFORMER

K-Number: K972034 · 1998-01-20

ApplicantPorex Surgical, Inc.
Decision Date1998-01-20
Product CodeHQN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MEDPOR OCULAR CONFORMER is the device name listed in this FDA 510(k) record. The listed applicant is Porex Surgical, Inc.. It received FDA 510(k) clearance on 1998-01-20 under 510(k) number K972034. The device is classified under product code HQN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDPOR OCULAR CONFORMER?

MEDPOR OCULAR CONFORMER is a medical device that received FDA 510(k) clearance on 1998-01-20. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K972034.

When did MEDPOR OCULAR CONFORMER receive FDA 510(k) clearance?

MEDPOR OCULAR CONFORMER received FDA 510(k) clearance on 1998-01-20, under 510(k) number K972034.

Who is the listed applicant for MEDPOR OCULAR CONFORMER?

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

What is the FDA product code for MEDPOR OCULAR CONFORMER?

The FDA product code for MEDPOR OCULAR CONFORMER is HQN.

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.

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Other records listing Porex Surgical, 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.

K102184MEDPOR CONTAIN CAN IMPLANTK101835MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079K091807MEDPOR FIXATION SYSTEMK091120MEDPOR CONTAIN IMPLANTK083621MEDPOR CUSTOMIZED SURGICAL IMPLANTK071335MEDPOR ATTRACTOR IMPLANT

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Related Devices (Code: HQN)

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.

K970319OCULAR CONFORMERXavier A. Guerra, Ocularist, Inc.K970318OCULAR CONFORMERSouthwest Artificial Eyes, Inc.K945110KOLBERG OPHTHALMIC CONFORMERKolberg Ocular Products, Inc.K921221STERILE/SINGLE USE SYMBLEPHARON RINGStorz Instrument Co.K921229STERILE/SINGLE USE OPHTHALMIC CONFORMERSStorz Instrument Co.K772168MOLDEYERobert B. Scott Ocularists of Florida, 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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