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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K950290
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 Number868.5630
Classification Product Code
CAF  
Date Received01/25/1995
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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