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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 K895192
Device Name SPINOCAN(R) CONTINUOUS SPINAL TRAY
Applicant
Burron Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Applicant Contact PEGGY KEIFFER
Correspondent
Burron Medical, Inc.
824 Twelfth Ave.
Bethlehem,  PA  18018
Correspondent Contact PEGGY KEIFFER
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received08/11/1989
Decision Date 09/18/1989
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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