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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 K944399
Device Name MEDI-PUMP
Applicant
Thomas Industries
1419 Illinois Ave.
Sheboygan,  WI  53082
Applicant Contact DAN PFISTER
Correspondent
Thomas Industries
1419 Illinois Ave.
Sheboygan,  WI  53082
Correspondent Contact DAN PFISTER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/08/1994
Decision Date 01/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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