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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name connector, airway (extension)
510(k) Number K954197
Device Name DISPOSABLE FLEX TUBE
Applicant
ENGSTROM MEDICAL
BOX 20109
KARLSBODAVAGEN 18
S-161 02 BROMMA,  SE
Applicant Contact WULF TREPTE
Correspondent
ENGSTROM MEDICAL
BOX 20109
KARLSBODAVAGEN 18
S-161 02 BROMMA,  SE
Correspondent Contact WULF TREPTE
Regulation Number868.5810
Classification Product Code
BZA  
Date Received09/06/1995
Decision Date 10/26/1995
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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