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 K980211
Device Name MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
Applicant
Manan Medical Products, Inc.
4445 SW 35th Ter.
Suite 310
Gainsville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Manan Medical Products, Inc.
4445 SW 35th Ter.
Suite 310
Gainsville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/21/1998
Decision Date 02/06/1998
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
-
-