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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Titrimetric, Fatty Acids
510(k) Number K792555
Device Name ELVI NON-ESTERIFIED FATTY ACIDS
Applicant
Volu Sol Medical Industries
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Volu Sol Medical Industries
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1290
Classification Product Code
JLH  
Date Received12/10/1979
Decision Date 01/16/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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