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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 K950592
Device Name ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES
Applicant
Eare Consulting Service
P.O. Box 1309
Eilat,  IL 88112
Applicant Contact EMANUEL A ROSEN
Correspondent
Eare Consulting Service
P.O. Box 1309
Eilat,  IL 88112
Correspondent Contact EMANUEL A ROSEN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/09/1995
Decision Date 06/01/1995
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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