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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K060193
Device Name MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
Applicant
OCEANIC MEDICAL PRODUCTS, INC.
555 THIRTEENTH STREET, NW.
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
OCEANIC MEDICAL PRODUCTS, INC.
555 THIRTEENTH STREET, NW.
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received01/25/2006
Decision Date 04/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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