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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Slides, Microscope
510(k) Number K890042
Device Name MICROSCOPE SLIDES PRECOATED
Applicant
Stat Path
P.O. Box 6
Riderwood,  MD  21139
Applicant Contact ELIZABETH BOSTWICK
Correspondent
Stat Path
P.O. Box 6
Riderwood,  MD  21139
Correspondent Contact ELIZABETH BOSTWICK
Regulation Number864.3010
Classification Product Code
KEW  
Date Received01/05/1989
Decision Date 01/13/1989
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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