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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 K000886
Device Name SPIROL EPIDURAL CATHETER
Applicant
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Applicant Contact JILL N SACKETT
Correspondent
ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact JILL N SACKETT
Regulation Number868.5120
Classification Product Code
BSO  
Date Received03/20/2000
Decision Date 10/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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