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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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