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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 K952103
Device Name AEROS ASPIRATOR
Applicant
Aeros Instruments, Inc.
1111 Lakeside Dr.
Gurnee,  IL  60031
Applicant Contact CHRIS GOSSETT
Correspondent
Aeros Instruments, Inc.
1111 Lakeside Dr.
Gurnee,  IL  60031
Correspondent Contact CHRIS GOSSETT
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/04/1995
Decision Date 07/31/1995
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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