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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K943605
Device Name BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS
Applicant
Baxter Healthcare Corp
1430 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact ROBERT E OLEWINE
Correspondent
Baxter Healthcare Corp
1430 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact ROBERT E OLEWINE
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/25/1994
Decision Date 08/17/1994
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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