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FDA 510(k)

TROJAN PLUS II

K-Number: K833765 · 1983-12-16

ApplicantYoungs Rubber Corp.
Decision Date1983-12-16
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROJAN PLUS II is the device name listed in this FDA 510(k) record. The listed applicant is Youngs Rubber Corp.. It received FDA 510(k) clearance on 1983-12-16 under 510(k) number K833765. 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 PLUS II?

TROJAN PLUS II is a medical device that received FDA 510(k) clearance on 1983-12-16. The listed applicant is Youngs Rubber Corp.. The 510(k) number is K833765.

When did TROJAN PLUS II receive FDA 510(k) clearance?

TROJAN PLUS II received FDA 510(k) clearance on 1983-12-16, under 510(k) number K833765.

Who is the listed applicant for TROJAN PLUS II?

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

What is the FDA product code for TROJAN PLUS II?

The FDA product code for TROJAN PLUS II 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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