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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 K935316
Device Name PARASAFE(R) FIXATIVE
Applicant
Scientific Device Laboratory, Inc.
508 Zenith Dr.
Glenview,  IL  60025
Applicant Contact STEWART LIPTON
Correspondent
Scientific Device Laboratory, Inc.
508 Zenith Dr.
Glenview,  IL  60025
Correspondent Contact STEWART LIPTON
Regulation Number866.2900
Classification Product Code
LKS  
Date Received11/02/1993
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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