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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 K951871
Device Name PISTON SYRINGE
Applicant
Baxa Corp.
13760 E. Arapahoe Rd.
Englewood,  CO  80112
Applicant Contact WILLIAM E MCKAY
Correspondent
Baxa Corp.
13760 E. Arapahoe Rd.
Englewood,  CO  80112
Correspondent Contact WILLIAM E MCKAY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/21/1995
Decision Date 06/21/1995
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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