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 needle, fistula
510(k) Number K002813
Device Name NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
Applicant
NIPRO MEDICAL CORP.
510 STONEMONT DR.
WESTON,  FL  33326
Applicant Contact RICHARD D BLISS
Correspondent
NIPRO MEDICAL CORP.
510 STONEMONT DR.
WESTON,  FL  33326
Correspondent Contact RICHARD D BLISS
Regulation Number876.5540
Classification Product Code
FIE  
Subsequent Product Code
FMI  
Date Received09/08/2000
Decision Date 11/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-