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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microtome, Rotary
510(k) Number K843505
Device Name LKB 2230 ROTARY ONE
Applicant
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Applicant Contact ED ZIOR
Correspondent
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Correspondent Contact ED ZIOR
Regulation Number864.3010
Classification Product Code
IDO  
Date Received09/06/1984
Decision Date 11/30/1984
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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