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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 K926566
Device Name CARE-E-VAC
Applicant
Aeros Instruments, Inc.
3411 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact JAMES A KOPPA
Correspondent
Aeros Instruments, Inc.
3411 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact JAMES A KOPPA
Regulation Number878.4780
Classification Product Code
BTA  
Date Received12/31/1992
Decision Date 07/09/1993
Decision Substantially Equivalent - Kit (SESK)
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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