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FDA 510(k)

AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS

K-Number: K062826 · 2007-05-22

ApplicantAlpha-Omega Services, Inc.
Decision Date2007-05-22
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Omega Services, Inc.. It received FDA 510(k) clearance on 2007-05-22 under 510(k) number K062826. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS?

AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is Alpha-Omega Services, Inc.. The 510(k) number is K062826.

When did AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS receive FDA 510(k) clearance?

AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS received FDA 510(k) clearance on 2007-05-22, under 510(k) number K062826.

Who is the listed applicant for AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS?

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

What is the FDA product code for AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS?

The FDA product code for AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS is JAQ.

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Other records listing Alpha-Omega Services, 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.

K233628AOS Interstitial Templates, Needles, and AccessoriesK233626AOS Marker Seeds (SMG0242-025)K102811AOS ORION IR-192 SOURCE CABLEK062824AOS UNIVERSAL CONECTING GUIDE TUBEK062823AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIESK062825AOS MARKER SEEDS

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Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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