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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 K070904
Device Name ANTLIA II SUCTION PUMP SYSTEM
Applicant
Innovative Therapies, Inc.
11 Vendue Ct.
Simpsonville,  SC  29681
Applicant Contact JUDITH HARBOUR
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/02/2007
Decision Date 04/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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