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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 K990748
Device Name EDGE SYSTEMS STERILE TUBING
Applicant
Edge Systems Corp.
30001 Golden Lantern #334
Laguna Niguel,  CA  92677
Applicant Contact GARY MOCNIK
Correspondent
Edge Systems Corp.
30001 Golden Lantern #334
Laguna Niguel,  CA  92677
Correspondent Contact GARY MOCNIK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/08/1999
Decision Date 05/04/1999
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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