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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condenser, heat and moisture (artificial nose)
510(k) Number K912700
Device Name FLOCARE DRY CAS SAMPLING PORT MODELS
Applicant
FLOCARE MEDICAL
992 EAGLE SCHOOL RD.
SUITE 913
WAYNE,  PA  19087
Applicant Contact AL W KRAUS
Correspondent
FLOCARE MEDICAL
992 EAGLE SCHOOL RD.
SUITE 913
WAYNE,  PA  19087
Correspondent Contact AL W KRAUS
Regulation Number868.5375
Classification Product Code
BYD  
Date Received06/19/1991
Decision Date 09/11/1991
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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