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FDA 510(k)

FASSIER-DUVAL TELSCOPIC IM SYSTEM

K-Number: K041393 · 2004-08-17

ApplicantPega Medical, Inc.
Decision Date2004-08-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FASSIER-DUVAL TELSCOPIC IM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pega Medical, Inc.. It received FDA 510(k) clearance on 2004-08-17 under 510(k) number K041393. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASSIER-DUVAL TELSCOPIC IM SYSTEM?

FASSIER-DUVAL TELSCOPIC IM SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-17. The listed applicant is Pega Medical, Inc.. The 510(k) number is K041393.

When did FASSIER-DUVAL TELSCOPIC IM SYSTEM receive FDA 510(k) clearance?

FASSIER-DUVAL TELSCOPIC IM SYSTEM received FDA 510(k) clearance on 2004-08-17, under 510(k) number K041393.

Who is the listed applicant for FASSIER-DUVAL TELSCOPIC IM SYSTEM?

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

What is the FDA product code for FASSIER-DUVAL TELSCOPIC IM SYSTEM?

The FDA product code for FASSIER-DUVAL TELSCOPIC IM SYSTEM is HSB.

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Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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