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 endoscopic injection needle, gastroenterology-urology
510(k) Number K951648
Device Name MIST ENDOSCOPIC NEEDLES
Applicant
MIST, INC.
55 NORTHERN BLVD.
GREAT NECK,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
MIST, INC.
55 NORTHERN BLVD.
GREAT NECK,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number876.1500
Classification Product Code
FBK  
Subsequent Product Code
FCG  
Date Received04/10/1995
Decision Date 05/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-