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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Marrow Collection/Transfusion Kit
510(k) Number K871198
Device Name BONE MARROW COLLECTION KIT AND STAND
Applicant
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact BUCHHOLZ, MD
Correspondent
Baxter Healthcare Corp
Rte. 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact BUCHHOLZ, MD
Classification Product Code
LWE  
Date Received03/24/1987
Decision Date 11/06/1987
Decision Substantially Equivalent (SESE)
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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