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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K061210
Device Name FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
Applicant
KYPHON, INC.
1221 CROSSMAN AVE.
SUNNYVALE,  CA  94089
Applicant Contact CINDY DOMECUS
Correspondent
KYPHON, INC.
1221 CROSSMAN AVE.
SUNNYVALE,  CA  94089
Correspondent Contact CINDY DOMECUS
Regulation Number868.5150
Classification Product Code
BSP  
Date Received05/01/2006
Decision Date 06/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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