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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K062456
Device Name NOVASPINE POWERED SUCTION PUMP PRO-1
Applicant
Novaspine, LLC
P.O. Box 205
Derby,  CT  06418
Applicant Contact DINA L WEISSMAN
Correspondent
Novaspine, LLC
P.O. Box 205
Derby,  CT  06418
Correspondent Contact DINA L WEISSMAN
Regulation Number878.4780
Classification Product Code
OMP  
Date Received08/23/2006
Decision Date 10/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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