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
510(k) Number K043388
Device Name PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
Applicant
Pegasus Biologics, Inc.
10 Pasteur St.
Suite 150
Irvine,  CA  92618
Applicant Contact MUIR S MEINHOLD
Correspondent
Pegasus Biologics, Inc.
10 Pasteur St.
Suite 150
Irvine,  CA  92618
Correspondent Contact MUIR S MEINHOLD
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWY   OXB   OXE  
Date Received12/09/2004
Decision Date 08/05/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-