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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vaporizer, anesthesia, non-heated
510(k) Number K954801
Device Name TECHFIL
Applicant
TECHNIMECA MEDIC, INC.
2300 COHEN
ST. LAURENT, QUEBEC,  CA H4R 2N8
Applicant Contact JACQUES ROBERGE
Correspondent
TECHNIMECA MEDIC, INC.
2300 COHEN
ST. LAURENT, QUEBEC,  CA H4R 2N8
Correspondent Contact JACQUES ROBERGE
Regulation Number868.5880
Classification Product Code
CAD  
Date Received10/19/1995
Decision Date 01/25/1996
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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