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FDA 510(k)

Harmony Latex Dam, Harmony Non-Latex Dam

K-Number: K203727 · 2021-08-05

ApplicantPamco Distributing, Inc.
Decision Date2021-08-05
Product CodeMSC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Harmony Latex Dam, Harmony Non-Latex Dam is a medical device manufactured by Pamco Distributing, Inc.. It received FDA 510(k) clearance on 2021-08-05 under approval number K203727. The device is classified under product code MSC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Harmony Latex Dam, Harmony Non-Latex Dam?

Harmony Latex Dam, Harmony Non-Latex Dam is a medical device that received FDA 510(k) clearance on 2021-08-05. It is manufactured by Pamco Distributing, Inc.. The 510(k) number is K203727.

When was Harmony Latex Dam, Harmony Non-Latex Dam approved by the FDA?

Harmony Latex Dam, Harmony Non-Latex Dam received FDA 510(k) clearance on 2021-08-05, under approval number K203727.

What company makes Harmony Latex Dam, Harmony Non-Latex Dam?

Harmony Latex Dam, Harmony Non-Latex Dam is manufactured by Pamco Distributing, Inc..

What is the FDA product code for Harmony Latex Dam, Harmony Non-Latex Dam?

The FDA product code for Harmony Latex Dam, Harmony Non-Latex Dam is MSC.

Related Devices (Code: MSC)

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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.

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