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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, General Purpose, Microbiology, Diagnostic
510(k) Number K862112
Device Name MICROSCOPE SLIDES
Applicant
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Applicant Contact PIYUSH M SHAH
Correspondent
Abco Dealers, Inc.
P.O. Box 17587
6637 N. Sidney Pl.
Milwaukee,  WI  53217
Correspondent Contact PIYUSH M SHAH
Regulation Number866.2660
Classification Product Code
LIB  
Date Received06/03/1986
Decision Date 06/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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