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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K844149
Device Name AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
Applicant
Ambu, Inc.
7 Old Sherman Tpke.
Danbury,  CT  06810
Applicant Contact ANDREA MOODY
Correspondent
Ambu, Inc.
7 Old Sherman Tpke.
Danbury,  CT  06810
Correspondent Contact ANDREA MOODY
Regulation Number868.5240
Classification Product Code
CAI  
Date Received10/24/1984
Decision Date 11/15/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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