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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 K854601
Device Name SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
Applicant
Concord Laboratories, Inc.
Kit St.
Keene,  NH  03431
Applicant Contact ROBERT WHEELER
Correspondent
Concord Laboratories, Inc.
Kit St.
Keene,  NH  03431
Correspondent Contact ROBERT WHEELER
Regulation Number868.5120
Classification Product Code
BSO  
Date Received11/18/1985
Decision Date 01/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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