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 K992499
Device Name GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
Applicant
GALLINI U.S., LLC.
3991 GLENSIDE DR., SUITE F
RICHMOND,  VA  23229
Applicant Contact PAUL L HAWTHORNE
Correspondent
GALLINI U.S., LLC.
3991 GLENSIDE DR., SUITE F
RICHMOND,  VA  23229
Correspondent Contact PAUL L HAWTHORNE
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/26/1999
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-