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FDA 510(k)

CEROS TCP GRANULES

K-Number: K101426 · 2010-09-15

ApplicantMathys, Ltd.
Decision Date2010-09-15
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEROS TCP GRANULES is the device name listed in this FDA 510(k) record. The listed applicant is Mathys, Ltd.. It received FDA 510(k) clearance on 2010-09-15 under 510(k) number K101426. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEROS TCP GRANULES?

CEROS TCP GRANULES is a medical device that received FDA 510(k) clearance on 2010-09-15. The listed applicant is Mathys, Ltd.. The 510(k) number is K101426.

When did CEROS TCP GRANULES receive FDA 510(k) clearance?

CEROS TCP GRANULES received FDA 510(k) clearance on 2010-09-15, under 510(k) number K101426.

Who is the listed applicant for CEROS TCP GRANULES?

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

What is the FDA product code for CEROS TCP GRANULES?

The FDA product code for CEROS TCP GRANULES is LYC.

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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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