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FDA 510(k)

JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS

K-Number: K854247 · 1986-01-16

ApplicantM/S Seohung Industrial Co., Ltd.
Decision Date1986-01-16
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS is the device name listed in this FDA 510(k) record. The listed applicant is M/S Seohung Industrial Co., Ltd.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K854247. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS?

JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is M/S Seohung Industrial Co., Ltd.. The 510(k) number is K854247.

When did JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS receive FDA 510(k) clearance?

JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS received FDA 510(k) clearance on 1986-01-16, under 510(k) number K854247.

Who is the listed applicant for JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS?

The FDA 510(k) record lists M/S Seohung Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS?

The FDA product code for JELLIA SKIN 1001 & LUBRICATED MILLION CONDOMS is HIS.

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Related Devices (Code: HIS)

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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