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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 K863396
Device Name CONCEPT INTRAVISION ARTHROSCOPE SYSTEM
Applicant
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Applicant Contact PENNY RASMUSSEN
Correspondent
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Correspondent Contact PENNY RASMUSSEN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/03/1986
Decision Date 09/12/1986
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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