Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-