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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 K080275
FOIA Releasable 510(k) K080275
Device Name NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Applicant
Iasis Medical, Inc.
6393 Oakgreen Ave.
Hastings,  MN  55033
Applicant Contact JOHN BUAN
Correspondent
Iasis Medical, Inc.
6393 Oakgreen Ave.
Hastings,  MN  55033
Correspondent Contact JOHN BUAN
Regulation Number878.4780
Classification Product Code
OMP  
Date Received02/01/2008
Decision Date 10/09/2008
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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