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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 K951988
Device Name PRESSURIZER
Applicant
Promedic, Inc.
10415 Briggs Ct.
Indianapolis,  IN  46256
Applicant Contact PAUL E DRYDEN
Correspondent
Promedic, Inc.
10415 Briggs Ct.
Indianapolis,  IN  46256
Correspondent Contact PAUL E DRYDEN
Regulation Number880.5420
Classification Product Code
KZD  
Date Received04/27/1995
Decision Date 06/14/1995
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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