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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, conduction, anesthetic
510(k) Number K081404
Device Name SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
Applicant
SPINAL INTEGRATION LLC
6314 KINGSPOINTE PKWY UNIT 6
ORLANDO,  FL  32819
Applicant Contact TRUDIE L SEEGER
Correspondent
SPINAL INTEGRATION LLC
6314 KINGSPOINTE PKWY UNIT 6
ORLANDO,  FL  32819
Correspondent Contact TRUDIE L SEEGER
Regulation Number868.5120
Classification Product Code
BSO  
Date Received05/19/2008
Decision Date 10/21/2008
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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