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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 K981089
Device Name TISSOMAT AND SPRAY SET
Applicant
BAXTER HEALTHCARE CORP.
550 NORTH BRAND BLVD.
GLENDALE,  CA  91023
Applicant Contact ANGELA BLACKSHERE
Correspondent
BAXTER HEALTHCARE CORP.
550 NORTH BRAND BLVD.
GLENDALE,  CA  91023
Correspondent Contact ANGELA BLACKSHERE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/25/1998
Decision Date 07/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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