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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtome, Cryostat
510(k) Number K883514
Device Name EXAKT CUTTING & GRINDING SYSTEM
Applicant
Exakt Medical Instruments, Inc.
1000 S. Mckinley P.O.Box
83343
Oklahoma City,  OK  73148
Applicant Contact LINDA E DURBIN
Correspondent
Exakt Medical Instruments, Inc.
1000 S. Mckinley P.O.Box
83343
Oklahoma City,  OK  73148
Correspondent Contact LINDA E DURBIN
Regulation Number864.3010
Classification Product Code
IDP  
Date Received08/17/1988
Decision Date 08/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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