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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 NORTH HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
Applicant Contact DAVID LEE
Correspondent
AMBU, INC.
611 NORTH HAMMONDS FERRY RD.
LINTHICUM,  MD  21090 -1356
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
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