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510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) NumberK993967
Device NameORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002
Applicant
ORATEC INTERVENTIONS, INC.
3700 haven ct.
menlo park,  CA  94025
Contactjennifer brennan
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/23/1999
Decision Date 12/17/1999
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 Special
Reviewed by Third Party No
Expedited Review No
 
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