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FDA 510(k)

DUREX PLAY WARMER LUBRICANT

K-Number: K042563 · 2005-02-23

ApplicantSsl Americas, Inc.
Decision Date2005-02-23
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DUREX PLAY WARMER 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 2005-02-23 under 510(k) number K042563. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUREX PLAY WARMER LUBRICANT?

DUREX PLAY WARMER LUBRICANT is a medical device that received FDA 510(k) clearance on 2005-02-23. The listed applicant is Ssl Americas, Inc.. The 510(k) number is K042563.

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

DUREX PLAY WARMER LUBRICANT received FDA 510(k) clearance on 2005-02-23, under 510(k) number K042563.

Who is the listed applicant for DUREX PLAY WARMER 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 WARMER LUBRICANT?

The FDA product code for DUREX PLAY WARMER LUBRICANT is KMJ.

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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 CONDOMK063385DUREX PLAY MASSAGE GEL LUBRICANTK060098DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTSK042958DUREX PLAY TINGLING LUBRICANTK042470DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOMK032227DUREX FLAVORED LATEX CONDOM

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Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal Corporation

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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