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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 K800232
Device Name ABCO ULTRA SLIDE MICROSCOPE SLIDE
Applicant
Abco Dealers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Abco Dealers, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.3010
Classification Product Code
KEW  
Date Received02/05/1980
Decision Date 02/21/1980
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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