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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K002763
Device Name REMREST
Applicant
MEDICAL INDUSTRIES AMERICA, INC.
2636 289TH PLACE
ADEL,  IA  50003 -8021
Applicant Contact ANNE B CARLSON
Correspondent
MEDICAL INDUSTRIES AMERICA, INC.
2636 289TH PLACE
ADEL,  IA  50003 -8021
Correspondent Contact ANNE B CARLSON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/05/2000
Decision Date 05/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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