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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Tissue, Automated
510(k) Number K851054
Device Name LX120 TISSUE PROCESSOR
Applicant
Innovative Medical Systems, Inc.
55 Steamwhistle Dr.
Ivyland,  PA  18974
Applicant Contact JOSEPH CATARIOUS
Correspondent
Innovative Medical Systems, Inc.
55 Steamwhistle Dr.
Ivyland,  PA  18974
Correspondent Contact JOSEPH CATARIOUS
Regulation Number864.3875
Classification Product Code
IEO  
Date Received03/14/1985
Decision Date 05/15/1985
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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