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 Mesh, Surgical, Polymeric
510(k) Number K090271
Device Name HYDROCOAT MESH
Applicant
PROMETHEAN SURGICAL DEVICES, INC.
111 ROBERTS ST., SUITE G2
EAST HARTFORD,  CT  06108
Applicant Contact KENNETH K KLEINHENZ
Correspondent
PROMETHEAN SURGICAL DEVICES, INC.
111 ROBERTS ST., SUITE G2
EAST HARTFORD,  CT  06108
Correspondent Contact KENNETH K KLEINHENZ
Regulation Number878.3300
Classification Product Code
FTL  
Date Received02/04/2009
Decision Date 01/14/2010
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
-
-