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FDA 510(k)

EMBEDDING TOOL, MODEL TE-1000

K-Number: K060897 · 2006-07-18

ApplicantMedigroup, Inc.
Decision Date2006-07-18
Product CodeFJS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EMBEDDING TOOL, MODEL TE-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Medigroup, Inc.. It received FDA 510(k) clearance on 2006-07-18 under 510(k) number K060897. The device is classified under product code FJS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBEDDING TOOL, MODEL TE-1000?

EMBEDDING TOOL, MODEL TE-1000 is a medical device that received FDA 510(k) clearance on 2006-07-18. The listed applicant is Medigroup, Inc.. The 510(k) number is K060897.

When did EMBEDDING TOOL, MODEL TE-1000 receive FDA 510(k) clearance?

EMBEDDING TOOL, MODEL TE-1000 received FDA 510(k) clearance on 2006-07-18, under 510(k) number K060897.

Who is the listed applicant for EMBEDDING TOOL, MODEL TE-1000?

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

What is the FDA product code for EMBEDDING TOOL, MODEL TE-1000?

The FDA product code for EMBEDDING TOOL, MODEL TE-1000 is FJS.

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Other records listing Medigroup, 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.

K120130FALLER TROCARK071167FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560K070730FLEX-NECK ARC CATHETERK031351FLEX-NECK PD CATHETER, INFANTK974570PERITONEAL DIALYSIS CATHETER CONNECTOR

Related Devices (Code: FJS)

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.

K213602Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool KitCovidien, LLCK180485Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter ExtenderCovidien, LLCK130441FALLER STYLETMedionics International, Inc.K121383PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)Medical Components, Inc.K120130FALLER TROCARMedigroup, Inc.K113354VETA PERITONEAL DIALYSIS CATHETERPfm Medical, Inc.

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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