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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Non-Powered
510(k) Number K940973
Device Name MULLAN GANGLION MICROCOMPRESSION SET
Applicant
Cook, Inc.
925 S. Curry Pk
Bloomington,  IN  47403
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
925 S. Curry Pk
Bloomington,  IN  47403
Correspondent Contact APRIL LAVENDER
Regulation Number882.4535
Classification Product Code
HAO  
Date Received03/03/1994
Decision Date 09/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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