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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K863986
Device Name XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES
Applicant
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
Applicant Contact RONALD L DIECK
Correspondent
American Edwards Laboratories
P.O. Box 11150
17221 Red Hill Ave.(Irvine)
Santa Ana,  CA  92711
Correspondent Contact RONALD L DIECK
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/14/1986
Decision Date 10/31/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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