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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 K822434
Device Name CREST PRESSURE INFUSOR
Applicant
Crest Medical Equipment
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Crest Medical Equipment
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5420
Classification Product Code
KZD  
Date Received08/13/1982
Decision Date 09/17/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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