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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, Floor Standing
510(k) Number K893813
Device Name FLOOR STANDING, OPERATING AND EXAMINING LIGHT
Applicant
Astralite Corp.
6090-A Enterprise Dr.
Diamond Springs,  CA  95619
Applicant Contact SWARTZ
Correspondent
Astralite Corp.
6090-A Enterprise Dr.
Diamond Springs,  CA  95619
Correspondent Contact SWARTZ
Regulation Number878.4580
Classification Product Code
FSS  
Date Received05/23/1989
Decision Date 07/14/1989
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
Predetermined Change
Control Plan Authorized		 No
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