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 Stimulator, Spinal-Cord, Implanted (Pain Relief)
510(k) Number K081208
Device Name CINCH ANCHOR, MODEL 1194
Applicant
ADVANCED NEUROMODULATION SYSTEMS
6901 PRESTON RD.
PLANO,  TX  75024
Applicant Contact PENNY HOUSTON
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
6901 PRESTON RD.
PLANO,  TX  75024
Correspondent Contact PENNY HOUSTON
Regulation Number882.5880
Classification Product Code
GZB  
Subsequent Product Code
GZF  
Date Received04/29/2008
Decision Date 07/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-