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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K920471
Device Name LEVY ARTICULATING RETRACTOR
Applicant
LIFEGUARD MEDICAL PRODUCTS, INC.
400 LATHROP AVE.
SUITE 200
RIVER FOREST,  IL  60305
Applicant Contact DOUGLAS HULFISH
Correspondent
LIFEGUARD MEDICAL PRODUCTS, INC.
400 LATHROP AVE.
SUITE 200
RIVER FOREST,  IL  60305
Correspondent Contact DOUGLAS HULFISH
Regulation Number878.4800
Classification Product Code
GAD  
Subsequent Product Code
FGM  
Date Received01/28/1992
Decision Date 06/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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