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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 K072702
Device Name STRYKER ANTIMIC CATHETER
Applicant
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact JULIE PRYOR
Correspondent
STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact JULIE PRYOR
Regulation Number868.5120
Classification Product Code
BSO  
Date Received09/24/2007
Decision Date 03/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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