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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Formaldehyde (Formalin, Formol)
510(k) Number K792705
Device Name PARA-PAK FORMALIN
Applicant
Meridian Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Meridian Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.4010
Classification Product Code
IGG  
Date Received12/27/1979
Decision Date 01/21/1980
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
Recalls CDRH Recalls
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