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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K993167
Device Name MILLENNIUM INFANT VENTILATOR
Applicant
Sechrist Industries, Inc.
4225 E. La Palma
Anaheim,  CA  92807
Applicant Contact GREG GODFREY
Correspondent
Sechrist Industries, Inc.
4225 E. La Palma
Anaheim,  CA  92807
Correspondent Contact GREG GODFREY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/22/1999
Decision Date 11/10/1999
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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