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FDA 510(k)

CS-11

K-Number: K832500 · 1983-10-27

ApplicantChema-Scutum, Inc.
Decision Date1983-10-27
Product CodeEBE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CS-11 is the device name listed in this FDA 510(k) record. The listed applicant is Chema-Scutum, Inc.. It received FDA 510(k) clearance on 1983-10-27 under 510(k) number K832500. The device is classified under product code EBE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS-11?

CS-11 is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Chema-Scutum, Inc.. The 510(k) number is K832500.

When did CS-11 receive FDA 510(k) clearance?

CS-11 received FDA 510(k) clearance on 1983-10-27, under 510(k) number K832500.

Who is the listed applicant for CS-11?

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

What is the FDA product code for CS-11?

The FDA product code for CS-11 is EBE.

Related Devices (Code: EBE)

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.

K830491JOHNSON & JOHNSON OPAQUE COLOR MODIFIJohnson & Johnson Professionals, Inc.K790339CONCEPT IIRichardson Merrel, Inc.

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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