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 Prosthesis, Wrist, Hemi-, Ulnar
510(k) Number K081025
Device Name ISOELASTICU
Applicant
Remi Sciences, Inc.
745 Bent Creek Dr.
Lititz,  PA  17543
Applicant Contact SANJIV H NAIDU
Correspondent
Remi Sciences, Inc.
745 Bent Creek Dr.
Lititz,  PA  17543
Correspondent Contact SANJIV H NAIDU
Regulation Number888.3810
Classification Product Code
KXE  
Date Received04/10/2008
Decision Date 11/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-