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FDA 510(k)

MITAKA POINT SETTER

K-Number: K991989 · 1999-08-27

ApplicantMitaka USA, Inc.
Decision Date1999-08-27
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MITAKA POINT SETTER is the device name listed in this FDA 510(k) record. The listed applicant is Mitaka USA, Inc.. It received FDA 510(k) clearance on 1999-08-27 under 510(k) number K991989. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITAKA POINT SETTER?

MITAKA POINT SETTER is a medical device that received FDA 510(k) clearance on 1999-08-27. The listed applicant is Mitaka USA, Inc.. The 510(k) number is K991989.

When did MITAKA POINT SETTER receive FDA 510(k) clearance?

MITAKA POINT SETTER received FDA 510(k) clearance on 1999-08-27, under 510(k) number K991989.

Who is the listed applicant for MITAKA POINT SETTER?

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

What is the FDA product code for MITAKA POINT SETTER?

The FDA product code for MITAKA POINT SETTER is GWG.

Related Clinical Trials

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Other records listing Mitaka USA, 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.

K984355POINT SETTER

Related Devices (Code: GWG)

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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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