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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 K802506
Device Name PLEASCENT OR FORMA-SCENT
Applicant
Meridian Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Meridian Diagnostics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.4010
Classification Product Code
IGG  
Date Received10/15/1980
Decision Date 11/12/1980
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
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