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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 K904193
Device Name FLOCARE
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 Received09/12/1990
Decision Date 11/29/1990
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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