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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K914933
Device Name HEART PACK III
Applicant
Westmark Hospital Supplies
1253 Ramona SE
Grand Rapids,  MI  49507
Applicant Contact MARJORIE L SCHMLIDT
Correspondent
Westmark Hospital Supplies
1253 Ramona SE
Grand Rapids,  MI  49507
Correspondent Contact MARJORIE L SCHMLIDT
Regulation Number876.5130
Classification Product Code
KOD  
Date Received11/04/1991
Decision Date 01/31/1992
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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