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FDA 510(k)

NIRVANA D PERSONAL LUBRICANT (TBD)

K-Number: K123427 · 2013-06-28

ApplicantChurch & Dwight Co., Inc.
Decision Date2013-06-28
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NIRVANA D PERSONAL LUBRICANT (TBD) is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2013-06-28 under 510(k) number K123427. 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 NIRVANA D PERSONAL LUBRICANT (TBD)?

NIRVANA D PERSONAL LUBRICANT (TBD) is a medical device that received FDA 510(k) clearance on 2013-06-28. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K123427.

When did NIRVANA D PERSONAL LUBRICANT (TBD) receive FDA 510(k) clearance?

NIRVANA D PERSONAL LUBRICANT (TBD) received FDA 510(k) clearance on 2013-06-28, under 510(k) number K123427.

Who is the listed applicant for NIRVANA D PERSONAL LUBRICANT (TBD)?

The FDA 510(k) record lists Church & Dwight Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIRVANA D PERSONAL LUBRICANT (TBD)?

The FDA product code for NIRVANA D PERSONAL LUBRICANT (TBD) is NUC.

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Other records listing Church & Dwight Co., Inc. 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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