K(13 1355 Page I Premarket Notification CONCEIVE PLUS® Flipbook PDF

K(13 1355-Page I of 4 51 0(k) Premarket Notification CONCEIVE PLUS® 510(K) SUMMARY 510(k) K131355 SUBMITTER SASMAR, INC.

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51 0(k) Premarket Notification CONCEIVE PLUS®

510(K) SUMMARY 510(k)

K131355

SUBMITTER

SASMAR, INC. 155 North Wacker Drive Chicago, IL 60606

CONTCTPESON CONTACT PERSON

John-Michael Mancini

Chief Executive Officer

Tel: (773) 942 0030

Nv0727 NV0721

Fax: (773) 337 9148

MANUFACTURER

SASMAR SPRL 40-42 rue dle 'Association 1000 Brussels Belgium Tel +32 2 880 8220 Fax +32 2 880 8221

PREPARATION DATE

6 November, 2013

TRADE NAME

CONCEIVE PLUS®

CLASSIFICATION NAME

Personal Lubricant

CLASSIFICATION PANEL

Condom Class 11 (21 CER 884.5300)

PRODUCT CODE

FEB (lubricant, personal, gamete, fertilization, and embryo compatible)

PREDICATE DEVICE (Primary)

Pre-Va Vaginal Lubricant (K