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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
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