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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, cutting, orthopedic
510(k) Number K850423
Device Name CONCEPT SUCTION SLEEVE
Applicant
CONCEPT, INC.
12707 U.S. 19 SOUTH
CLEARWATER,  FL  33546
Applicant Contact PENNY RASMUSSEN
Correspondent
CONCEPT, INC.
12707 U.S. 19 SOUTH
CLEARWATER,  FL  33546
Correspondent Contact PENNY RASMUSSEN
Regulation Number878.4800
Classification Product Code
HTZ  
Date Received02/04/1985
Decision Date 03/14/1985
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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