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FDA 510(k)

PARALLAX TRACER RADIOPAQUE PARTICLES

K-Number: K991893 · 1999-08-13

ApplicantParallax Medical, Inc.
Decision Date1999-08-13
Product CodeMYU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PARALLAX TRACER RADIOPAQUE PARTICLES is the device name listed in this FDA 510(k) record. The listed applicant is Parallax Medical, Inc.. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K991893. The device is classified under product code MYU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARALLAX TRACER RADIOPAQUE PARTICLES?

PARALLAX TRACER RADIOPAQUE PARTICLES is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Parallax Medical, Inc.. The 510(k) number is K991893.

When did PARALLAX TRACER RADIOPAQUE PARTICLES receive FDA 510(k) clearance?

PARALLAX TRACER RADIOPAQUE PARTICLES received FDA 510(k) clearance on 1999-08-13, under 510(k) number K991893.

Who is the listed applicant for PARALLAX TRACER RADIOPAQUE PARTICLES?

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

What is the FDA product code for PARALLAX TRACER RADIOPAQUE PARTICLES?

The FDA product code for PARALLAX TRACER RADIOPAQUE PARTICLES is MYU.

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 Parallax Medical, 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.

K033230TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TAK023445TRACERS BONE CEMENT OPACIFIERK022169CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLESK011206PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLESK994022PARALLAX CRANIOSET

Related Devices (Code: MYU)

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.

K033230TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TAParallax Medical, Inc.K032388BONE CEMENT RADIO-OPACIFIERCardinalhealthK024359VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1Vista Scientific, LLCK023445TRACERS BONE CEMENT OPACIFIERParallax Medical, Inc.K002063BIOTRACE, MODEL 1730Bryan Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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