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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 K063071
Device Name DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR 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 Received10/06/2006
Decision Date 04/13/2007
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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