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FDA 510(k)

RENEW

K-Number: K982729 · 1998-09-15

ApplicantBisco, Inc.
Decision Date1998-09-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RENEW is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 1998-09-15 under 510(k) number K982729. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENEW?

RENEW is a medical device that received FDA 510(k) clearance on 1998-09-15. The listed applicant is Bisco, Inc.. The 510(k) number is K982729.

When did RENEW receive FDA 510(k) clearance?

RENEW received FDA 510(k) clearance on 1998-09-15, under 510(k) number K982729.

Who is the listed applicant for RENEW?

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

What is the FDA product code for RENEW?

The FDA product code for RENEW is EBF.

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Other records listing Bisco, Inc. as applicant

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Related Devices (Code: EBF)

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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