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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K894053
Device Name 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR
Applicant
Fenem, Inc.
84 William St.
16th Floor
New York,  NY  10038
Applicant Contact SHEILA GLENNON
Correspondent
Fenem, Inc.
84 William St.
16th Floor
New York,  NY  10038
Correspondent Contact SHEILA GLENNON
Regulation Number868.1400
Classification Product Code
CCK  
Date Received06/07/1989
Decision Date 07/20/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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