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FDA 510(k)

OMNITRON GYN APPLICATOR SYSTEM

K-Number: K913908 · 1992-03-06

ApplicantOmnitron Intl., Inc.
Decision Date1992-03-06
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNITRON GYN APPLICATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omnitron Intl., Inc.. It received FDA 510(k) clearance on 1992-03-06 under 510(k) number K913908. 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 OMNITRON GYN APPLICATOR SYSTEM?

OMNITRON GYN APPLICATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1992-03-06. The listed applicant is Omnitron Intl., Inc.. The 510(k) number is K913908.

When did OMNITRON GYN APPLICATOR SYSTEM receive FDA 510(k) clearance?

OMNITRON GYN APPLICATOR SYSTEM received FDA 510(k) clearance on 1992-03-06, under 510(k) number K913908.

Who is the listed applicant for OMNITRON GYN APPLICATOR SYSTEM?

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

What is the FDA product code for OMNITRON GYN APPLICATOR SYSTEM?

The FDA product code for OMNITRON GYN APPLICATOR SYSTEM is JAQ.

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Other records listing Omnitron Intl., Inc. as applicant

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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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