FDA 510(k) Application Details - K060098

Device Classification Name Lubricant, Patient, Vaginal, Latex Compatible

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510(K) Number K060098
Device Name Lubricant, Patient, Vaginal, Latex Compatible
Applicant SSL AMERICAS, INC.
3585 ENGINEERING DR.
SUITE 200
NORCROSS, GA 30092 US
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Contact CHRIS ROBINSON
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Regulation Number 884.5300

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Classification Product Code NUC
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Date Received 01/13/2006
Decision Date 06/08/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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