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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 K854255
Device Name SPAN / AID SYRINGE
Applicant
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Applicant Contact CHARLES B MITCHELL
Correspondent
Span-America Medical Systems, Inc.
P.O. Box 5231
Greenville,  SC  29606
Correspondent Contact CHARLES B MITCHELL
Regulation Number880.5860
Classification Product Code
FMF  
Date Received10/22/1985
Decision Date 11/12/1985
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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