DUREX PLAY WARMER LUBRICANT— 510(k) K042563

Substantially Equivalent

Ssl Americas, Inc.

FDA 510(k) clearance K042563 for DUREX PLAY WARMER LUBRICANT, Substantially Equivalent on 2005-02-23. Applicant: Ssl Americas, Inc.. Device class: 1.

Clearance details

Applicant: Ssl Americas, Inc.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 2004-09-21
Decision date: 2005-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ssl Americas, Inc.

K072169 — DUREX SYNTHETIC POLYISOPRENE MALE CONDOM2008-06-19
K063385 — DUREX PLAY MASSAGE GEL LUBRICANT2008-03-10
K060098 — DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS2006-06-08
K042958 — DUREX PLAY TINGLING LUBRICANT2005-04-08
K042470 — DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM2005-04-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.