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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 -2624
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
925 S. Curry Pk
Bloomington,  IN  47403 -2624
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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