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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 K001731
Device Name AVID-NIT LOSS OF RESISTANCE SYRINGE
Applicant
AVID MEDICAL, INC.
9000 WESTMONT DR.
STONEHOUSE COMMERCE PARK
TOANO,  VA  23168
Applicant Contact SEAN F SHEMANSKI
Correspondent
AVID MEDICAL, INC.
9000 WESTMONT DR.
STONEHOUSE COMMERCE PARK
TOANO,  VA  23168
Correspondent Contact SEAN F SHEMANSKI
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/07/2000
Decision Date 08/29/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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