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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 K965059
Device Name CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
Applicant
THOMAS INDUSTRIES
1419 ILLINOIS AVE.
SHEBOYGAN,  WI  53082 -0029
Applicant Contact DAN PFISTER
Correspondent
THOMAS INDUSTRIES
1419 ILLINOIS AVE.
SHEBOYGAN,  WI  53082 -0029
Correspondent Contact DAN PFISTER
Regulation Number878.4780
Classification Product Code
BTA  
Subsequent Product Code
JCX  
Date Received12/18/1996
Decision Date 03/04/1997
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
Recalls CDRH Recalls
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