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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 K830499
Device Name ESA ELECTROSURGICAL ARTHROSCOPY GENERA
Applicant
CONCEPT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CONCEPT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/16/1983
Decision Date 03/17/1983
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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