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FDA 510(k)

MEDIFIX INC.

K-Number: K992483 · 1999-08-30

ApplicantMedifix, Inc.
Decision Date1999-08-30
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDIFIX INC. is the device name listed in this FDA 510(k) record. The listed applicant is Medifix, Inc.. It received FDA 510(k) clearance on 1999-08-30 under 510(k) number K992483. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIFIX INC.?

MEDIFIX INC. is a medical device that received FDA 510(k) clearance on 1999-08-30. The listed applicant is Medifix, Inc.. The 510(k) number is K992483.

When did MEDIFIX INC. receive FDA 510(k) clearance?

MEDIFIX INC. received FDA 510(k) clearance on 1999-08-30, under 510(k) number K992483.

Who is the listed applicant for MEDIFIX INC.?

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

What is the FDA product code for MEDIFIX INC.?

The FDA product code for MEDIFIX INC. is FAJ.

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 Medifix, 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.

K011325MEDIFIX URETEROSCOPEK992480MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPESK992474ARTHROSCOPE / MEDIFIX INC.

Related Devices (Code: FAJ)

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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