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 K081826
Device Name INTELLIGENT STRAIGHT AND ARTICULAR ENDOSCOPIC LINEAR CUTTERS, VASCULAR WITH RELOADS, MODELS I30V, I45V, 160V, IR30V
Applicant
POWER MEDICAL INTERVENTIONS, INC.
2021 CABOT BLVD.
LANGHORNE,  PA  19047
Applicant Contact BARBARA J WHITMAN
Correspondent
POWER MEDICAL INTERVENTIONS, INC.
2021 CABOT BLVD.
LANGHORNE,  PA  19047
Correspondent Contact BARBARA J WHITMAN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received06/27/2008
Decision Date 07/25/2008
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
Recalls CDRH Recalls
-
-