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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 K813320
Device Name MODEL 6200 OXYGEN CONCENTRATOR
Applicant
Hudson Oxygen Therapy Sales Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hudson Oxygen Therapy Sales Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/24/1981
Decision Date 12/31/1981
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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