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FDA 510(k)

PROFA

K-Number: K981911 · 1998-11-12

ApplicantDuncan Hynd Associates, Ltd.
Decision Date1998-11-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROFA is the device name listed in this FDA 510(k) record. The listed applicant is Duncan Hynd Associates, Ltd.. It received FDA 510(k) clearance on 1998-11-12 under 510(k) number K981911. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFA?

PROFA is a medical device that received FDA 510(k) clearance on 1998-11-12. The listed applicant is Duncan Hynd Associates, Ltd.. The 510(k) number is K981911.

When did PROFA receive FDA 510(k) clearance?

PROFA received FDA 510(k) clearance on 1998-11-12, under 510(k) number K981911.

Who is the listed applicant for PROFA?

The FDA 510(k) record lists Duncan Hynd Associates, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROFA?

The FDA product code for PROFA is IYE.

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 Duncan Hynd Associates, Ltd. 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.

K002608INVAC

Related Devices (Code: IYE)

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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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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