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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 K952918
Device Name PTFE SYRINGE FILTER
Applicant
B.Braun Medical, Inc.
805 Grandview Dr.
So. San Francisco,  CA  94080
Applicant Contact MARK ALSBERGE
Correspondent
B.Braun Medical, Inc.
805 Grandview Dr.
So. San Francisco,  CA  94080
Correspondent Contact MARK ALSBERGE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/26/1995
Decision Date 09/15/1995
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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