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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 K770369
Device Name VACON TM
Applicant
Diemolding Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Diemolding Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6740
Classification Product Code
CBD  
Date Received02/24/1977
Decision Date 03/01/1977
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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