FDA 510(k)

CSR

K-Number: K974865 · 1998-03-16

Decision Date1998-03-16

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CSR is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1998-03-16 under 510(k) number K974865. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CSR?

CSR is a medical device that received FDA 510(k) clearance on 1998-03-16. The listed applicant is Parkell, Inc.. The 510(k) number is K974865.

When did CSR receive FDA 510(k) clearance?

CSR received FDA 510(k) clearance on 1998-03-16, under 510(k) number K974865.

Who is the listed applicant for CSR?

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

What is the FDA product code for CSR?

The FDA product code for CSR is EBI.

Other records listing Parkell, 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.

K243254Parkell Pit and Fissure Sealant K210259Parkell Self-Adhesive Cement K191103Parkell Desensitizer Gel K190930SmarTemp X1 K182296HyperFil-LV K172176Parkell Universal Adhesive

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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.