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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Operating-Room
510(k) Number K781581
Device Name SURGICAL LIGHT 22 SERIES
Applicant
AMERICAN STERILIZER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN STERILIZER CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4580
Classification Product Code
FQP  
Date Received09/15/1978
Decision Date 10/17/1978
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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