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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusor, Pressure, For I.V. Bags
510(k) Number K780465
Device Name VOLUME CONTROL DEVICE VCD-150
Applicant
Sorensen Research
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sorensen Research
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5420
Classification Product Code
KZD  
Date Received03/22/1978
Decision Date 06/02/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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