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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter
510(k) Number K873009
Device Name CONCEPT SWITCHING STICK
Applicant
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Applicant Contact LORI COLVIN
Correspondent
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Correspondent Contact LORI COLVIN
Regulation Number878.4200
Classification Product Code
KGZ  
Date Received08/04/1987
Decision Date 08/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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