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FDA 510(k)

DUREX PLAY MASSAGE GEL LUBRICANT

K-Number: K063385 · 2008-03-10

ApplicantSsl Americas, Inc.
Decision Date2008-03-10
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DUREX PLAY MASSAGE GEL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Ssl Americas, Inc.. It received FDA 510(k) clearance on 2008-03-10 under 510(k) number K063385. 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 DUREX PLAY MASSAGE GEL LUBRICANT?

DUREX PLAY MASSAGE GEL LUBRICANT is a medical device that received FDA 510(k) clearance on 2008-03-10. The listed applicant is Ssl Americas, Inc.. The 510(k) number is K063385.

When did DUREX PLAY MASSAGE GEL LUBRICANT receive FDA 510(k) clearance?

DUREX PLAY MASSAGE GEL LUBRICANT received FDA 510(k) clearance on 2008-03-10, under 510(k) number K063385.

Who is the listed applicant for DUREX PLAY MASSAGE GEL LUBRICANT?

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

What is the FDA product code for DUREX PLAY MASSAGE GEL LUBRICANT?

The FDA product code for DUREX PLAY MASSAGE GEL LUBRICANT is NUC.

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Other records listing Ssl Americas, Inc. as applicant

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.

K072169DUREX SYNTHETIC POLYISOPRENE MALE CONDOMK060098DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTSK042958DUREX PLAY TINGLING LUBRICANTK042470DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOMK042563DUREX PLAY WARMER LUBRICANTK032227DUREX FLAVORED LATEX CONDOM

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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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