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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K892938
Device Name AMNIO-GROW TM
Applicant
Inovar Biologicals, Inc.
7807 Cessna Ave.
Gaithersburg,  MD  20879
Applicant Contact KEITH LATHAM
Correspondent
Inovar Biologicals, Inc.
7807 Cessna Ave.
Gaithersburg,  MD  20879
Correspondent Contact KEITH LATHAM
Regulation Number864.2220
Classification Product Code
KIT  
Date Received04/21/1989
Decision Date 05/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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