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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 K781887
Device Name 9100 DAYSTAR AND 9110 ORBITER PACKAGE
Applicant
CASTLE CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CASTLE CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4580
Classification Product Code
FSY  
Date Received11/07/1978
Decision Date 12/12/1978
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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