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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 K955014
Device Name APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE
Applicant
Applied Optronics Corp.
111 Corporate Blvd.
Bldg. J
South Plainfield,  NJ  07080
Applicant Contact DOUGLASS MEAD
Correspondent
Applied Optronics Corp.
111 Corporate Blvd.
Bldg. J
South Plainfield,  NJ  07080
Correspondent Contact DOUGLASS MEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/01/1995
Decision Date 01/26/1996
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
Predetermined Change
Control Plan Authorized		 No
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