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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K032598
Device Name SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
Applicant
Synergetics, Inc.
3845 Corporate Centre Dr.
St. Charles,  MO  63304
Applicant Contact DAN REGAN
Correspondent
Synergetics, Inc.
3845 Corporate Centre Dr.
St. Charles,  MO  63304
Correspondent Contact DAN REGAN
Regulation Number876.1500
Classification Product Code
MPA  
Subsequent Product Code
GEX  
Date Received08/25/2003
Decision Date 11/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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