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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K964975
Device Name COHORT DISCECTOMY SYSTEMS (CDS)
Applicant
Cohort Medical Products Group, Inc.
3583 Investment Blvd., #5
Hayward,  CA  94545
Applicant Contact RONALD C ALLEN
Correspondent
Cohort Medical Products Group, Inc.
3583 Investment Blvd., #5
Hayward,  CA  94545
Correspondent Contact RONALD C ALLEN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/12/1996
Decision Date 02/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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