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FDA 510(k)

TOTAL CURE

K-Number: K010196 · 2001-04-05

ApplicantBisco, Inc.
Decision Date2001-04-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOTAL CURE is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2001-04-05 under 510(k) number K010196. 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 TOTAL CURE?

TOTAL CURE is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Bisco, Inc.. The 510(k) number is K010196.

When did TOTAL CURE receive FDA 510(k) clearance?

TOTAL CURE received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010196.

Who is the listed applicant for TOTAL CURE?

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 TOTAL CURE?

The FDA product code for TOTAL CURE 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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