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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 K073516
Device Name DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
Applicant
KYPHON, INC.
1221 CROSSMAN AVE.
SUNNYVALE,  CA  94089
Applicant Contact PAMELA SEGALE
Correspondent
KYPHON, INC.
1221 CROSSMAN AVE.
SUNNYVALE,  CA  94089
Correspondent Contact PAMELA SEGALE
Regulation Number868.5150
Classification Product Code
BSP  
Date Received12/14/2007
Decision Date 02/21/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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