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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 K904538
Device Name MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT
Applicant
Mauna Loa Medical, Inc.
3305 Springmountain Rd., #60
Las Vegas,  NV  89102
Applicant Contact JAMES WEIGL
Correspondent
Mauna Loa Medical, Inc.
3305 Springmountain Rd., #60
Las Vegas,  NV  89102
Correspondent Contact JAMES WEIGL
Regulation Number868.5240
Classification Product Code
CAI  
Date Received10/04/1990
Decision Date 04/24/1991
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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