FDA 510(k)

Steri-Dot Process Indicator

K-Number: K210866 · 2021-06-21

ApplicantPropper Manufacturing Co., Inc.

Decision Date2021-06-21

Product CodeJOJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Steri-Dot Process Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Propper Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2021-06-21 under 510(k) number K210866. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steri-Dot Process Indicator?

Steri-Dot Process Indicator is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Propper Manufacturing Co., Inc.. The 510(k) number is K210866.

When did Steri-Dot Process Indicator receive FDA 510(k) clearance?

Steri-Dot Process Indicator received FDA 510(k) clearance on 2021-06-21, under 510(k) number K210866.

Who is the listed applicant for Steri-Dot Process Indicator?

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

What is the FDA product code for Steri-Dot Process Indicator?

The FDA product code for Steri-Dot Process Indicator is JOJ.

Other records listing Propper Manufacturing Co., 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.

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Related Devices (Code: JOJ)

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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.