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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 K904013
Device Name SPIVE NEEDLE SYSTEM, MODIFICATION
Applicant
Pascall Medical Corp.
4857 Battery Ln., #304
Bethesda,  MD  20814
Applicant Contact WILLIAM R TARELLO
Correspondent
Pascall Medical Corp.
4857 Battery Ln., #304
Bethesda,  MD  20814
Correspondent Contact WILLIAM R TARELLO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/29/1990
Decision Date 10/01/1990
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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