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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, Ceiling Mounted
510(k) Number K943288
Device Name AMSCO SQ240 SURGICAL LIGHT
Applicant
American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Applicant Contact MICHAEL ZMUDA
Correspondent
American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Correspondent Contact MICHAEL ZMUDA
Regulation Number878.4580
Classification Product Code
FSY  
Date Received07/08/1994
Decision Date 10/17/1994
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
Predetermined Change
Control Plan Authorized		 No
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