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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K903404
Device Name FLOCARE F
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 Number868.5975
Classification Product Code
BZO  
Date Received07/31/1990
Decision Date 09/25/1990
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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