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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, accessories
510(k) Number K935102
Device Name SATURN LIGHT
Applicant
BURTON MEDICAL PRODUCTS CORP.
7922 HASKELL AVE.
VAN NUYS,  CA  91406
Applicant Contact GRETEL LUMLEY
Correspondent
BURTON MEDICAL PRODUCTS CORP.
7922 HASKELL AVE.
VAN NUYS,  CA  91406
Correspondent Contact GRETEL LUMLEY
Regulation Number878.4580
Classification Product Code
FTA  
Date Received10/22/1993
Decision Date 06/27/1994
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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