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 K954596
Device Name PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM
Applicant
PROMEDICAL LTD.
240 BRAEN AVE.
WYCKOFF,  NJ  07481
Applicant Contact HENRY V SIERAKOWSKI
Correspondent
PROMEDICAL LTD.
240 BRAEN AVE.
WYCKOFF,  NJ  07481
Correspondent Contact HENRY V SIERAKOWSKI
Regulation Number876.1075
Classification Product Code
FCG  
Date Received10/03/1995
Decision Date 10/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-