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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K852134
Device Name BSM 22 BLOOD SAFETY MODULE
Applicant
Hospal Medical Corp.
25 Kimberly Rd.
P.O. Box 857
East Brunswick,  NJ  08816
Applicant Contact FRESSINET
Correspondent
Hospal Medical Corp.
25 Kimberly Rd.
P.O. Box 857
East Brunswick,  NJ  08816
Correspondent Contact FRESSINET
Regulation Number876.5820
Classification Product Code
KOC  
Date Received05/16/1985
Decision Date 06/12/1985
Decision Substantially Equivalent (SESE)
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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