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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
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