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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 K043500
Device Name FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE
Applicant
INNOSPINE, INC.
11240 MAGDALENA ROAD
LOS ALTOS HILLS,  CA  94024
Applicant Contact LARAINE PANGELINA
Correspondent
INNOSPINE, INC.
11240 MAGDALENA ROAD
LOS ALTOS HILLS,  CA  94024
Correspondent Contact LARAINE PANGELINA
Regulation Number868.5150
Classification Product Code
BSP  
Date Received12/20/2004
Decision Date 04/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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