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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Breathing System (Calibrated)
510(k) Number K780340
Device Name IMV SYSTEM
Applicant
LKB INSTRUMENTS, INC.
KS 
Correspondent
LKB INSTRUMENTS, INC.
KS 
Regulation Number880.6740
Classification Product Code
CBD  
Date Received03/01/1978
Decision Date 11/27/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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