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 Biopsy Needle
510(k) Number K962569
Device Name BIOMID BONE MARROW BIOPSY NEEDLE
Applicant
GALLINI INTL., INC.
1454 ROCKAWAY PKWY., SUITE 300
BROOKLYN,  NY  11236
Applicant Contact CATERINA E GALLUZZO
Correspondent
GALLINI INTL., INC.
1454 ROCKAWAY PKWY., SUITE 300
BROOKLYN,  NY  11236
Correspondent Contact CATERINA E GALLUZZO
Regulation Number876.1075
Classification Product Code
FCG  
Date Received07/01/1996
Decision Date 11/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-