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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Parasite Concentration
510(k) Number K933370
Device Name STOOL TRANSPORT/PROCESSOR
Applicant
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014 -8172
Applicant Contact GREGORY T DAVIS
Correspondent
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014 -8172
Correspondent Contact GREGORY T DAVIS
Regulation Number866.2900
Classification Product Code
LKS  
Date Received07/09/1993
Decision Date 02/17/1994
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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