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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, Fiberoptic
510(k) Number K000728
Device Name MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
Applicant
Medtronic Xomed
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact DAVID TIMLIN
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact CAROLE STAMP
Regulation Number878.4580
Classification Product Code
FST  
Date Received03/06/2000
Decision Date 03/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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