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FDA 510(k)

KING KONDOM (CONDOM)

K-Number: K882009 · 1988-09-21

ApplicantKing Kondom Products, Inc.
Decision Date1988-09-21
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KING KONDOM (CONDOM) is the device name listed in this FDA 510(k) record. The listed applicant is King Kondom Products, Inc.. It received FDA 510(k) clearance on 1988-09-21 under 510(k) number K882009. 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 KING KONDOM (CONDOM)?

KING KONDOM (CONDOM) is a medical device that received FDA 510(k) clearance on 1988-09-21. The listed applicant is King Kondom Products, Inc.. The 510(k) number is K882009.

When did KING KONDOM (CONDOM) receive FDA 510(k) clearance?

KING KONDOM (CONDOM) received FDA 510(k) clearance on 1988-09-21, under 510(k) number K882009.

Who is the listed applicant for KING KONDOM (CONDOM)?

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

What is the FDA product code for KING KONDOM (CONDOM)?

The FDA product code for KING KONDOM (CONDOM) 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

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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