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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 K900353
Device Name SHIELDED PIGGYBACK IV NEEDLE
Applicant
Pascall Saringia Medical Corp.
Suite 416, Cape Royal Bldg.
1980 N. Atlantic Ave.
Cocoa Beach,  FL  32931
Applicant Contact KORNBERG, MD
Correspondent
Pascall Saringia Medical Corp.
Suite 416, Cape Royal Bldg.
1980 N. Atlantic Ave.
Cocoa Beach,  FL  32931
Correspondent Contact KORNBERG, MD
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/25/1990
Decision Date 06/22/1990
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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