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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 K911970
Device Name NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE
Applicant
NASORCAP ENT., INC.
1077 HUSTON DR.
WEST MIFFLIN,  PA  15122
Applicant Contact STEVEN J DERRICK
Correspondent
NASORCAP ENT., INC.
1077 HUSTON DR.
WEST MIFFLIN,  PA  15122
Correspondent Contact STEVEN J DERRICK
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/03/1991
Decision Date 08/14/1992
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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