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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe
510(k) Number K943472
Device Name COHORT AVB RETRACTOR SYSTEM
Applicant
Cohort Medical Products Group, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Applicant Contact MARK URBANSKI
Correspondent
Cohort Medical Products Group, Inc.
25590 Seaboard Ln.
Hayward,  CA  94545
Correspondent Contact MARK URBANSKI
Regulation Number888.4540
Classification Product Code
HXB  
Date Received07/19/1994
Decision Date 10/20/1994
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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