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FDA 510(k)

ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON

K-Number: K983478 · 1998-11-09

ApplicantOrganic Essentials
Decision Date1998-11-09
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON is the device name listed in this FDA 510(k) record. The listed applicant is Organic Essentials. It received FDA 510(k) clearance on 1998-11-09 under 510(k) number K983478. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON?

ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON is a medical device that received FDA 510(k) clearance on 1998-11-09. The listed applicant is Organic Essentials. The 510(k) number is K983478.

When did ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON receive FDA 510(k) clearance?

ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON received FDA 510(k) clearance on 1998-11-09, under 510(k) number K983478.

Who is the listed applicant for ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON?

The FDA 510(k) record lists Organic Essentials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON?

The FDA product code for ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON is HEB.

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Related Devices (Code: HEB)

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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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.

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