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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Elastomeric
510(k) Number K060933
Device Name SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
Applicant
Apex Medical Technologies, Inc.
10064 Mesa Ridge Ct., #202
San Diego,  CA  92121
Applicant Contact WHITNEY WILLIAMS
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number880.5725
Classification Product Code
MEB  
Date Received04/05/2006
Decision Date 05/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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