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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, reusable
510(k) Number K953082
Device Name ILIAC CREST BONE MARROW ASPIRATION NEEDLE
Applicant
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
BLDG. K
MCGAW PARK,  IL  60085
Applicant Contact SHARON RICHTER
Correspondent
BAXTER HEALTHCARE CORP.
1500 WAUKEGAN RD.
BLDG. K
MCGAW PARK,  IL  60085
Correspondent Contact SHARON RICHTER
Regulation Number878.4800
Classification Product Code
GDM  
Subsequent Product Code
DWO  
Date Received07/03/1995
Decision Date 09/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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