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 staple, implantable
510(k) Number K030653
Device Name SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS
Applicant
POWER MEDICAL INTERVENTIONS, INC.
110 UNION SQUARE DR.
NEW HOPE,  PA  18938 -1364
Applicant Contact BABARA J WHITMAN
Correspondent
POWER MEDICAL INTERVENTIONS, INC.
110 UNION SQUARE DR.
NEW HOPE,  PA  18938 -1364
Correspondent Contact BABARA J WHITMAN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received03/03/2003
Decision Date 03/31/2003
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
-
-