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FDA 510(k)

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.

K-Number: K902305 · 1991-03-29

ApplicantArmkel, LLC
Decision Date1991-03-29
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K902305. 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 NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.?

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Armkel, LLC. The 510(k) number is K902305.

When did TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. receive FDA 510(k) clearance?

TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. received FDA 510(k) clearance on 1991-03-29, under 510(k) number K902305.

Who is the listed applicant for TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.?

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 NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM.?

The FDA product code for TROJAN NATURALAMB NATURAL MEMBRANE CONDOM W/SPERM. 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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