FDA 510(k)

U-15 SINGLE END SCALER

K-Number: K901171 · 1990-04-16

ApplicantAmerican Medical Ceramics, Inc.

Decision Date1990-04-16

Product CodeEKJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

U-15 SINGLE END SCALER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Ceramics, Inc.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K901171. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-15 SINGLE END SCALER?

U-15 SINGLE END SCALER is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is American Medical Ceramics, Inc.. The 510(k) number is K901171.

When did U-15 SINGLE END SCALER receive FDA 510(k) clearance?

U-15 SINGLE END SCALER received FDA 510(k) clearance on 1990-04-16, under 510(k) number K901171.

Who is the listed applicant for U-15 SINGLE END SCALER?

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

What is the FDA product code for U-15 SINGLE END SCALER?

The FDA product code for U-15 SINGLE END SCALER is EKJ.

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Other records listing American Medical Ceramics, Inc. as applicant

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Related Devices (Code: EKJ)

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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.