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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 K951345
Device Name DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
Applicant
CATHETER RESEARCH, INC.
6131 WEST 80TH ST.
INDIANAPOLIS,  IN  46278
Applicant Contact JOHN A STEEN
Correspondent
CATHETER RESEARCH, INC.
6131 WEST 80TH ST.
INDIANAPOLIS,  IN  46278
Correspondent Contact JOHN A STEEN
Regulation Number868.5810
Classification Product Code
BZA  
Date Received03/23/1995
Decision Date 04/14/1995
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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