Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Pamco Distributing, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) 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. The listed applicant is Pamco Distributing, Inc.. The 510(k) number is K203727.

When did Harmony Latex Dam, Harmony Non-Latex Dam receive FDA 510(k) clearance?

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

Who is the listed applicant for Harmony Latex Dam, Harmony Non-Latex Dam?

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

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)

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.

K253662LIXI (LXOSFM1)Luwi, LLCK212928LoralsBrazen Goods Inc. Dba LoralsK212037SancDam Latex Oral DamSanctuary Health Sdn. Bhd.

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.

↑