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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name valve, non-rebreathing
510(k) Number K941008
Device Name COMPLETE CPR KIT
Applicant
MTM HEALTH PRODUCTS LTD.
2349 FAIRVIEW ST.
BURLINGTON, ONTARIO, CANADA
L7R 2E3,  CA L7R 2E3
Applicant Contact FRANK SNAPE
Correspondent
MTM HEALTH PRODUCTS LTD.
2349 FAIRVIEW ST.
BURLINGTON, ONTARIO, CANADA
L7R 2E3,  CA L7R 2E3
Correspondent Contact FRANK SNAPE
Regulation Number868.5870
Classification Product Code
CBP  
Date Received03/01/1994
Decision Date 11/10/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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