DUREX PLAY WARMER LUBRICANT

Lubricant, Patient

SSL AMERICAS, INC.

The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Play Warmer Lubricant.

Pre-market Notification Details

Device IDK042563
510k NumberK042563
Device Name:DUREX PLAY WARMER LUBRICANT
ClassificationLubricant, Patient
Applicant SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross,  GA  30092
ContactChris Robinson
CorrespondentChris Robinson
SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross,  GA  30092
Product CodeKMJ  
CFR Regulation Number880.6375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2004-09-21
Decision Date2005-02-23
Summary:summary

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