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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 K913327
Device Name CONTEMPRO2 HOME HEALTH CARE REGULATOR
Applicant
Continental Products, Inc.
54 Evergreen Dr.
Portland,  ME  04104
Applicant Contact BARRY A SCHWARTZ
Correspondent
Continental Products, Inc.
54 Evergreen Dr.
Portland,  ME  04104
Correspondent Contact BARRY A SCHWARTZ
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/25/1991
Decision Date 12/20/1991
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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