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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File
510(k) Number K862659
Device Name CONCEPT ARTHROSCOPY RASP
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 Number888.4540
Classification Product Code
HTP  
Date Received07/14/1986
Decision Date 09/02/1986
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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