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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K861011
Device Name SILENT PARTNER MODEL 10-2001
Applicant
Medical Devices, Inc.
5000 Dufferin St., Unit N
Downsview
Ontario M3h 5t5,  CA
Applicant Contact STEVEN SERBER
Correspondent
Medical Devices, Inc.
5000 Dufferin St., Unit N
Downsview
Ontario M3h 5t5,  CA
Correspondent Contact STEVEN SERBER
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/18/1986
Decision Date 04/04/1986
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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