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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Punch, Surgical
510(k) Number K902636
Device Name LIPOGEN RHEUMELISA DSDNA ASSAY
Applicant
Lipogen, Inc.
10515 Research Dr.
Knoxville,  TN  37932
Applicant Contact MOKROS, M.S.
Correspondent
Lipogen, Inc.
10515 Research Dr.
Knoxville,  TN  37932
Correspondent Contact MOKROS, M.S.
Regulation Number878.4800
Classification Product Code
LRY  
Date Received06/14/1990
Decision Date 06/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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