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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 K032301
Device Name NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900
Applicant
Neogen Technologies, Inc.
5353 NW 35th Ave.
Ft Lauderdale,  FL  33309
Applicant Contact LYDIA B BIGGIE
Correspondent
Neogen Technologies, Inc.
5353 NW 35th Ave.
Ft Lauderdale,  FL  33309
Correspondent Contact LYDIA B BIGGIE
Regulation Number878.4780
Classification Product Code
OMP  
Date Received07/25/2003
Decision Date 08/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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