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FDA 510(k)

ROEKO SEAL

K-Number: K983037 · 1998-10-20

ApplicantRoeko Ulm, Roescheisen GmbH & Co.
Decision Date1998-10-20
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROEKO SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Roeko Ulm, Roescheisen GmbH & Co.. It received FDA 510(k) clearance on 1998-10-20 under 510(k) number K983037. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROEKO SEAL?

ROEKO SEAL is a medical device that received FDA 510(k) clearance on 1998-10-20. The listed applicant is Roeko Ulm, Roescheisen GmbH & Co.. The 510(k) number is K983037.

When did ROEKO SEAL receive FDA 510(k) clearance?

ROEKO SEAL received FDA 510(k) clearance on 1998-10-20, under 510(k) number K983037.

Who is the listed applicant for ROEKO SEAL?

The FDA 510(k) record lists Roeko Ulm, Roescheisen GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROEKO SEAL?

The FDA product code for ROEKO SEAL is KIF.

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Related Devices (Code: KIF)

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

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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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