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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K990568
Device Name SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01
Applicant
Synergetics, Inc.
88 Hubble Dr.
St. Charles,  MO  63304
Applicant Contact KURT W GAMPP
Correspondent
Synergetics, Inc.
88 Hubble Dr.
St. Charles,  MO  63304
Correspondent Contact KURT W GAMPP
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/23/1999
Decision Date 05/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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