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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K983367
Device Name QLICKSMART
Applicant
Handren Assoc.
5818 Pr. Caroline Pl.
Leesburg,  FL  34748
Applicant Contact ROBERT T HANDREN JR
Correspondent
Handren Assoc.
5818 Pr. Caroline Pl.
Leesburg,  FL  34748
Correspondent Contact ROBERT T HANDREN JR
Regulation Number880.5570
Classification Product Code
MMK  
Date Received09/24/1998
Decision Date 11/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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