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, Removable (Skin)
510(k) Number K943719
Device Name VISISTAT STAPLER
Applicant
PILLING WECK, INC.
1 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact PONZELL ROYSTER
Correspondent
PILLING WECK, INC.
1 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact PONZELL ROYSTER
Regulation Number878.4760
Classification Product Code
GDT  
Date Received08/01/1994
Decision Date 08/24/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-