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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 K932031
Device Name AMBU PORTABLE SUCTION UNIT
Applicant
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090
Applicant Contact DAVID LEE
Correspondent
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090
Correspondent Contact DAVID LEE
Regulation Number878.4780
Classification Product Code
BTA  
Date Received04/27/1993
Decision Date 05/05/1995
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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