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FDA 510(k)

LAITINEN'S TRIGEMINUS STEREOGUIDE

K-Number: K881132 · 1988-08-09

ApplicantSandstrom Trade & Technology, Inc.
Decision Date1988-08-09
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LAITINEN'S TRIGEMINUS STEREOGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Sandstrom Trade & Technology, Inc.. It received FDA 510(k) clearance on 1988-08-09 under 510(k) number K881132. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAITINEN'S TRIGEMINUS STEREOGUIDE?

LAITINEN'S TRIGEMINUS STEREOGUIDE is a medical device that received FDA 510(k) clearance on 1988-08-09. The listed applicant is Sandstrom Trade & Technology, Inc.. The 510(k) number is K881132.

When did LAITINEN'S TRIGEMINUS STEREOGUIDE receive FDA 510(k) clearance?

LAITINEN'S TRIGEMINUS STEREOGUIDE received FDA 510(k) clearance on 1988-08-09, under 510(k) number K881132.

Who is the listed applicant for LAITINEN'S TRIGEMINUS STEREOGUIDE?

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

What is the FDA product code for LAITINEN'S TRIGEMINUS STEREOGUIDE?

The FDA product code for LAITINEN'S TRIGEMINUS STEREOGUIDE is HAW.

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 Sandstrom Trade & Technology, 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.

K881131THE LAITINEN STEREOTACTIC SYSTEM

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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