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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 K861201
Device Name FORMALDEHYDE SOLUTION, 37%
Applicant
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Applicant Contact URBAN, HT
Correspondent
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Correspondent Contact URBAN, HT
Regulation Number864.4010
Classification Product Code
IGG  
Date Received03/31/1986
Decision Date 04/11/1986
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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