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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K843585
Device Name BEMCO PORTABLE OXYGEN INHALATOR
Applicant
Bemco, Inc.
25 Sass Rd., R.R.#4
Chatham Ont. N7m 5j4,  CA
Applicant Contact AUSTIN L BEARD
Correspondent
Bemco, Inc.
25 Sass Rd., R.R.#4
Chatham Ont. N7m 5j4,  CA
Correspondent Contact AUSTIN L BEARD
Regulation Number868.2700
Classification Product Code
CAN  
Date Received09/11/1984
Decision Date 10/12/1984
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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