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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 K894709
Device Name NIDEK MODEL ADC-8000
Applicant
Nidek, Inc.
2460 Embarcadero Way
P.O.Box 50488
Palo Alto,  CA  94303
Applicant Contact KEN KATO
Correspondent
Nidek, Inc.
2460 Embarcadero Way
P.O.Box 50488
Palo Alto,  CA  94303
Correspondent Contact KEN KATO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/24/1989
Decision Date 10/04/1989
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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