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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K860352
Device Name SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014
Applicant
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Applicant Contact HANS, P.E.
Correspondent
Spacelabs, Inc.
20550 Prairie St.
Chatsworth,  CA  91311
Correspondent Contact HANS, P.E.
Regulation Number868.5810
Classification Product Code
BZA  
Date Received01/30/1986
Decision Date 03/19/1986
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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