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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 K883599
Device Name LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC)
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 Received08/23/1988
Decision Date 09/02/1988
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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