Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

510(k) Premarket Notification

Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
 

New Search Back To Search Results
Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) NumberK974464
Device NameORATEC SPINECATH INTRADISCAL CATHETER
Applicant
ORATEC INTERVENTIONS, INC.
3700 haven ct.
menlo park,  CA  94025
Contactmichael kwan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/26/1997
Decision Date 03/19/1998
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Statement/Summary/Purged Status Summary/purged 510(k)
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
 
-
-
-
-
-