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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Surgical And Accessories
510(k) Number K850749
Device Name CONCEPT VIDEO IMAGING SYSTEM
Applicant
CONCEPT, INC.
12707 U.S. 19 SOUTH
CLEARWATER,  FL  33546
Applicant Contact PENNY C RASMUSSEN
Correspondent
CONCEPT, INC.
12707 U.S. 19 SOUTH
CLEARWATER,  FL  33546
Correspondent Contact PENNY C RASMUSSEN
Regulation Number878.4160
Classification Product Code
KQM  
Date Received02/25/1985
Decision Date 05/20/1985
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
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