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 clip, hemostatic
510(k) Number K040148
Device Name RESOLUTION HEMOSTASIS CLIPPING DEVICE
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact JAMES D MCMAHON
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact JAMES D MCMAHON
Regulation Number878.4300
Classification Product Code
MCH  
Date Received01/23/2004
Decision Date 04/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-