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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 K853938
Device Name LX 300 TISSUE PROCESSOR
Applicant
INNOVATIVE MEDICAL SYSTEMS, INC.
55 STEAM WHISTLE DR.
IVYLAND,  PA  18974
Applicant Contact JOSEPH CATARIOUS
Correspondent
INNOVATIVE MEDICAL SYSTEMS, INC.
55 STEAM WHISTLE DR.
IVYLAND,  PA  18974
Correspondent Contact JOSEPH CATARIOUS
Regulation Number864.3875
Classification Product Code
IEO  
Date Received09/24/1985
Decision Date 10/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
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