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 Instrument, Biopsy
510(k) Number K902077
Device Name T19S BIOPSY NEEDLE
Applicant
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Applicant Contact DENNIS R LACKEY
Correspondent
Ohio Medical Instrument Co., Inc.
3924 Virginia Ave.
Cincinnati,  OH  45227
Correspondent Contact DENNIS R LACKEY
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/08/1990
Decision Date 07/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-