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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 K770812
Device Name HANDLES, LIGHT, SURGICAL, STEOILE
Applicant
Sybron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sybron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4580
Classification Product Code
FQP  
Date Received05/03/1977
Decision Date 05/23/1977
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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