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FDA 510(k)

MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES

K-Number: K992480 · 1999-09-23

ApplicantMedifix, Inc.
Decision Date1999-09-23
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Medifix, Inc.. It received FDA 510(k) clearance on 1999-09-23 under 510(k) number K992480. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES?

MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES is a medical device that received FDA 510(k) clearance on 1999-09-23. The listed applicant is Medifix, Inc.. The 510(k) number is K992480.

When did MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES receive FDA 510(k) clearance?

MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES received FDA 510(k) clearance on 1999-09-23, under 510(k) number K992480.

Who is the listed applicant for MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES?

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 SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES?

The FDA product code for MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES is HET.

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.

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.

Related Devices (Code: HET)

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.

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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