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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Patient
510(k) Number K042563
Device Name DUREX PLAY WARMER LUBRICANT
Applicant
Ssl Americas, Inc.
3585 Engineering Dr.
Suite 200
Norcross,  GA  30092
Applicant Contact CHRIS ROBINSON
Correspondent
Ssl Americas, Inc.
3585 Engineering Dr.
Suite 200
Norcross,  GA  30092
Correspondent Contact CHRIS ROBINSON
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received09/21/2004
Decision Date 02/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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