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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K890679
Device Name SCALP VEIN SET
Applicant
ASHLEY HEALTH CARE, INC.
P.O. BOX 1106
DOYLESTOWN,  PA  18901
Applicant Contact JOHN W ASHLEY
Correspondent
ASHLEY HEALTH CARE, INC.
P.O. BOX 1106
DOYLESTOWN,  PA  18901
Correspondent Contact JOHN W ASHLEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/09/1989
Decision Date 05/01/1989
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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