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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K882335
Device Name DISPOSABLE SYRINGE
Applicant
Baxter Healthcare Corp
P.O. Box 11150
Santa Ana,  CA  92711
Applicant Contact J KRATTENMAKER
Correspondent
Baxter Healthcare Corp
P.O. Box 11150
Santa Ana,  CA  92711
Correspondent Contact J KRATTENMAKER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/06/1988
Decision Date 06/16/1988
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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