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 Marker, Radiographic, Implantable
510(k) Number K072216
Device Name KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536
Applicant
Kapp Surgical Instrument, Inc.
4919 Warrensville Center Rd.
Warrensville,  OH  44128
Applicant Contact ALBERT N SANTILLI
Correspondent
Kapp Surgical Instrument, Inc.
4919 Warrensville Center Rd.
Warrensville,  OH  44128
Correspondent Contact ALBERT N SANTILLI
Regulation Number878.4300
Classification Product Code
NEU  
Date Received08/09/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-