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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 K790409
Device Name LOW DEAD SPACE INSULIN SYRINGE
Applicant
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5860
Classification Product Code
FMF  
Date Received02/26/1979
Decision Date 04/24/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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