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FDA 510(k)

OCL CONTOUR

K-Number: K945035 · 1994-11-15

ApplicantM-Pact Worldwide, LLC
Decision Date1994-11-15
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCL CONTOUR is the device name listed in this FDA 510(k) record. The listed applicant is M-Pact Worldwide, LLC. It received FDA 510(k) clearance on 1994-11-15 under 510(k) number K945035. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCL CONTOUR?

OCL CONTOUR is a medical device that received FDA 510(k) clearance on 1994-11-15. The listed applicant is M-Pact Worldwide, LLC. The 510(k) number is K945035.

When did OCL CONTOUR receive FDA 510(k) clearance?

OCL CONTOUR received FDA 510(k) clearance on 1994-11-15, under 510(k) number K945035.

Who is the listed applicant for OCL CONTOUR?

The FDA 510(k) record lists M-Pact Worldwide, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCL CONTOUR?

The FDA product code for OCL CONTOUR is DXQ.

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Related Devices (Code: DXQ)

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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