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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name anesthesia conduction kit
510(k) Number K854518
Device Name EPIDURAL ANESTHESIA TRAY
Applicant
OMNIS SURGICAL, INC.
1 BAXTER PARKWAY 3-2W
DEERFIELD,  IL  60015
Applicant Contact THOMAS D NICKEL
Correspondent
OMNIS SURGICAL, INC.
1 BAXTER PARKWAY 3-2W
DEERFIELD,  IL  60015
Correspondent Contact THOMAS D NICKEL
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received11/12/1985
Decision Date 12/23/1985
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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