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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 K082415
Device Name PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
Applicant
Premco Medical Systems, Inc.
699 Main St.
New Rochelle,  NY  10801
Applicant Contact HAROLD JACOBS
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number878.4780
Classification Product Code
OMP  
Date Received08/21/2008
Decision Date 11/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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