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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 K832274
Device Name ASPIRATOR
Applicant
Wells Johnson Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Wells Johnson Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4780
Classification Product Code
BTA  
Date Received07/12/1983
Decision Date 10/20/1983
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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