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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K041199
Device Name MEDI-PUMP ASPIRATOR, MODEL 1615
Applicant
Thomas Industries
1419 Illinois Ave.
Sheboygan,  WI  53082
Applicant Contact DANIEL PFISTER
Correspondent
Thomas Industries
1419 Illinois Ave.
Sheboygan,  WI  53082
Correspondent Contact DANIEL PFISTER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/07/2004
Decision Date 06/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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