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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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