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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fixative, Alcohol Containing
510(k) Number K881922
Device Name CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE
Applicant
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Applicant Contact JOY F MONEK
Correspondent
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Correspondent Contact JOY F MONEK
Regulation Number864.4010
Classification Product Code
LDZ  
Date Received05/09/1988
Decision Date 05/25/1988
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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