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FDA 510(k)

TROJAN PASSION BERRY GEL

K-Number: K013433 · 2002-03-05

ApplicantArmkel, LLC
Decision Date2002-03-05
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROJAN PASSION BERRY GEL is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 2002-03-05 under 510(k) number K013433. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROJAN PASSION BERRY GEL?

TROJAN PASSION BERRY GEL is a medical device that received FDA 510(k) clearance on 2002-03-05. The listed applicant is Armkel, LLC. The 510(k) number is K013433.

When did TROJAN PASSION BERRY GEL receive FDA 510(k) clearance?

TROJAN PASSION BERRY GEL received FDA 510(k) clearance on 2002-03-05, under 510(k) number K013433.

Who is the listed applicant for TROJAN PASSION BERRY GEL?

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 PASSION BERRY GEL?

The FDA product code for TROJAN PASSION BERRY GEL is NUC.

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Other records listing Armkel, LLC as applicant

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Related Devices (Code: NUC)

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.

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

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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