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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Mounting, Oil Soluble
510(k) Number K830659
Device Name CLEARIUM, MOUNTING MEDIUM
Applicant
Surgipath Medical Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Surgipath Medical Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.4010
Classification Product Code
KEP  
Date Received03/02/1983
Decision Date 03/17/1983
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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