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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K992902
Device Name AMBU HAND POWER SUCTION PUMP
Applicant
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090 -1356
Applicant Contact SANJAY PARIKH
Correspondent
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090 -1356
Correspondent Contact SANJAY PARIKH
Regulation Number868.6810
Classification Product Code
BSY  
Subsequent Product Codes
BYY   KTR  
Date Received08/30/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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