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FDA 510(k)

TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR

K-Number: K904000 · 1991-02-19

ApplicantArmkel, LLC
Decision Date1991-02-19
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K904000. 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 TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR?

TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Armkel, LLC. The 510(k) number is K904000.

When did TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR receive FDA 510(k) clearance?

TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR received FDA 510(k) clearance on 1991-02-19, under 510(k) number K904000.

Who is the listed applicant for TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR?

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

What is the FDA product code for TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR?

The FDA product code for TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR is HIS.

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Related Devices (Code: HIS)

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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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