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FDA 510(k)

F-SERIES IMPLANT

K-Number: K850706 · 1985-04-10

ApplicantOmni Intl., Inc.
Decision Date1985-04-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

F-SERIES IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Omni Intl., Inc.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K850706. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F-SERIES IMPLANT?

F-SERIES IMPLANT is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Omni Intl., Inc.. The 510(k) number is K850706.

When did F-SERIES IMPLANT receive FDA 510(k) clearance?

F-SERIES IMPLANT received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850706.

Who is the listed applicant for F-SERIES IMPLANT?

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

What is the FDA product code for F-SERIES IMPLANT?

The FDA product code for F-SERIES IMPLANT is DZE.

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Other records listing Omni Intl., 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.

K984066OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIMK984064OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREEK853255OMNIMED I.V. SOLUTION ADMIN. SETK851938OMNIMED SURGICAL GOWNK851654OMNIMED CLAMPK851734OMNIMED SUPERIOR TRANSDUCER PROTECTOR

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Related Devices (Code: DZE)

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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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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