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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 K820159
Device Name PRESSURE INFUSER
Applicant
DAVID CLARK COMPANY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DAVID CLARK COMPANY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5420
Classification Product Code
KZD  
Date Received01/20/1982
Decision Date 04/21/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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